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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02060630
Registration number
NCT02060630
Ethics application status
Date submitted
6/02/2014
Date registered
12/02/2014
Date last updated
11/04/2023
Titles & IDs
Public title
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
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Scientific title
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
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Secondary ID [1]
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1U01HL107407
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Secondary ID [2]
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BEST-CLI Trial
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Universal Trial Number (UTN)
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Trial acronym
BEST-CLI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Limb Ischemia
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Open surgical revascularization
Treatment: Devices - Endovascular revascularization
Other: Available vein, open surg. revasc. - Subjects with an available SSGSV cohort randomized to open surgical revascularization
Other: Available vein, endovasc. revasc. - Subjects with an available SSGSV cohort randomized to endovascular revascularization
Other: Alternative conduit, open surg. revasc. - Subjects with an alternative conduit cohort randomized to open surgical revascularization
Other: Alternative conduit, endovasc. revasc. - Subjects with an alternative conduit cohort randomized to endovascular revascularization
Treatment: Surgery: Open surgical revascularization
Treatment: Devices: Endovascular revascularization
A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)
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Assessment method [1]
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Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available
Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV
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Timepoint [1]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [1]
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Clinical: Re-intervention and amputation-free survival (cohort 1)
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Assessment method [1]
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Time to re-intervention of the index leg, above ankle amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available
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Timepoint [1]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [2]
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Clinical: Re-intervention and amputation-free survival (cohort 2)
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Assessment method [2]
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Time to re-intervention of the index leg, above ankle amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV
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Timepoint [2]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [3]
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Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)
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Assessment method [3]
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Time to re-intervention of the index leg, amputation of the index leg, or death within 30 days of index procedure, whichever occurs first in subjects with SSGSV available
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Timepoint [3]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [4]
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Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2)
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Assessment method [4]
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Time to re-intervention of the index leg, amputation of the index leg, or death within 30 days of index procedure, whichever occurs first in subjects without available SSGSV
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Timepoint [4]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [5]
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Clinical: Amputation-free survival (cohort 1)
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Assessment method [5]
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Time to amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available
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Timepoint [5]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [6]
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Clinical: Amputation-free survival (cohort 2)
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Assessment method [6]
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Time to amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV
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Timepoint [6]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [7]
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Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1)
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Assessment method [7]
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Time to death within 30 days of index procedure in subjects with SSGSV available
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Timepoint [7]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [8]
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Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2)
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Assessment method [8]
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Time to death within 30 days of index procedure in subjects without available SSGSV
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Timepoint [8]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [9]
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Clinical: Freedom from Myocardial Infarction (cohort 1)
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Assessment method [9]
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Time to myocardial infarction (MI) in subjects with SSGSV available
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Timepoint [9]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [10]
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Clinical: Freedom from Myocardial Infarction (cohort 2)
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Assessment method [10]
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Time to myocardial infarction (MI) in subjects without available SSGSV
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Timepoint [10]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [11]
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Clinical: Freedom from Stroke (cohort 1)
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Assessment method [11]
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Time to stroke in subjects with SSGSV available
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Timepoint [11]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [12]
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Clinical: Freedom from Stroke (cohort 2)
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Assessment method [12]
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Time to stroke in subjects without available SSGSV
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Timepoint [12]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [13]
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Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1)
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Assessment method [13]
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Time to re-intervention (major and minor) in index leg in subjects with SSGSV available
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Timepoint [13]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [14]
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Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2)
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Assessment method [14]
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Time to re-intervention (major and minor) in index leg in subjects without available SSGSV
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Timepoint [14]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [15]
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Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1)
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Assessment method [15]
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Number of re-interventions (major and minor) in per limb salvaged in subjects with SSGSV available
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Timepoint [15]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [16]
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Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2)
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Assessment method [16]
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Number of re-interventions (major and minor) in per limb salvaged in subjects without available SSGSV
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Timepoint [16]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [17]
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Clinical: Freedom from hemodynamic failure (cohort 1)
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Assessment method [17]
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Time to hemodynamic failure in subjects with SSGSV available
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Timepoint [17]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [18]
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Clinical: Freedom from hemodynamic failure (cohort 2)
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Assessment method [18]
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Time to hemodynamic failure in subjects without available SSGSV
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Timepoint [18]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [19]
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Clinical: Freedom from clinical failure (cohort 1)
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Assessment method [19]
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Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects with SSGSV available
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Timepoint [19]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [20]
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Clinical: Freedom from clinical failure (cohort 2)
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Assessment method [20]
0
0
Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects without available SSGSV
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Timepoint [20]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [21]
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Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1)
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Assessment method [21]
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Time to resolution of presenting CLI symptoms in the index limb in subjects with SSGSV available
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Timepoint [21]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [22]
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0
Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2)
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Assessment method [22]
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0
Time to resolution of presenting CLI symptoms in the index limb in subjects without available SSGSV
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Timepoint [22]
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0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [23]
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Clinical: Freedom from all-cause mortality (cohort 1)
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Assessment method [23]
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Time to all-cause mortality in subjects with SSGSV available
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Timepoint [23]
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0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [24]
0
0
Clinical: Freedom from all-cause mortality (cohort 2)
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Assessment method [24]
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0
Time to all-cause mortality in subjects without available SSGSV
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Timepoint [24]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [25]
0
0
Functional: Quality of Life assessment using VasuQoL (cohort 1)
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Assessment method [25]
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VasuQOL measurements in subjects with SSGSV available
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Timepoint [25]
0
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [26]
0
0
Functional: Quality of Life assessment using VasuQoL (cohort 2)
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Assessment method [26]
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VasuQOL measurements in subjects without available SSGSV
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Timepoint [26]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [27]
0
0
Functional: Quality of Life assessment using EuroQoL (cohort 1)
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Assessment method [27]
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EuroQOL measurements in subjects with SSGSV available
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Timepoint [27]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [28]
0
0
Functional: Quality of Life assessment using EuroQoL (cohort 2)
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Assessment method [28]
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EuroQOL measurements in subjects without available SSGSV
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Timepoint [28]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [29]
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0
Functional: Function assessment using SF-12, PCS (cohort 1)
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Assessment method [29]
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Physical Component Summary (PCS) scores in subjects with SSGSV available
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Timepoint [29]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [30]
0
0
Functional: Function assessment using SF-12, PCS (cohort 2)
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Assessment method [30]
0
0
Physical Component Summary (PCS) scores in subjects without available SSGSV
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Timepoint [30]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [31]
0
0
Functional: Function assessment using SF-12, MCS (cohort 1)
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Assessment method [31]
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0
Mental Component Summary (MCS) scores in subjects with SSGSV available
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Timepoint [31]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [32]
0
0
Functional: Function assessment using SF-12, MCS (cohort 2)
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Assessment method [32]
0
0
Mental Component Summary (MCS) scores in subjects without available SSGSV
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Timepoint [32]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [33]
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0
Functional: Function assessment using SF-12, SF-6D R2 (cohort 1)
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Assessment method [33]
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Utility Index (SF-6D R2) scores in subjects with SSGSV available
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Timepoint [33]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [34]
0
0
Functional: Function assessment using SF-12, SF-6D R2(cohort 2)
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Assessment method [34]
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0
Utility Index (SF-6D R2) scores in subjects without available SSGSV
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Timepoint [34]
0
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [35]
0
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Functional: Numerical rating scale for Pain, Pain Now (cohort 1)
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Assessment method [35]
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Scores for Pain Now in subjects with SSGSV available
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Timepoint [35]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [36]
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Functional: Numerical rating scale for Pain, Pain Now (cohort 2)
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Assessment method [36]
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Scores for Pain Now in subjects without available SSGSV
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Timepoint [36]
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [37]
0
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Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1)
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Assessment method [37]
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Scores for Usual level of Pain during the last week in subjects with SSGSV available
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Timepoint [37]
0
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Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [38]
0
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Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2)
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Assessment method [38]
0
0
Scores for Usual level of Pain during the last week in subjects without available SSGSV
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Timepoint [38]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [39]
0
0
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1)
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Assessment method [39]
0
0
Scores for Best level of Pain during the last week in subjects with SSGSV available
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Timepoint [39]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [40]
0
0
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2)
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Assessment method [40]
0
0
Scores for Best level of Pain during the last week in subjects without available SSGSV
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Timepoint [40]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [41]
0
0
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1)
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Assessment method [41]
0
0
Scores for Worst level of Pain during the last week in subjects with SSGSV available
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Timepoint [41]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Query!
Secondary outcome [42]
0
0
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2)
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Assessment method [42]
0
0
Scores for Worst level of Pain during the last week in subjects without available SSGSV
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Timepoint [42]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [43]
0
0
Function: Six-minute walk test (cohort 1)
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Assessment method [43]
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0
Six-minute walk test measurements in subjects with SSGSV available. The six-minute walk test was performed at a subset of clinical sites (for whom this test was standard of care) and was limited to patients for whom rest pain, wounds, or foot surgery (recent or anticipated) did not preclude weight bearing
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Timepoint [43]
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0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Secondary outcome [44]
0
0
Function: Six-minute walk test (cohort 2)
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Assessment method [44]
0
0
Six-minute walk test measurements in subjects without available SSGSV. The six-minute walk test was performed at a subset of clinical sites (for whom this test was standard of care) and was limited to patients for whom rest pain, wounds, or foot surgery (recent or anticipated) did not preclude weight bearing
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Timepoint [44]
0
0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
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Eligibility
Key inclusion criteria
1. Male or female, age 18 years or older.
2. Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament).
3. CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or
rest pain consistent with Rutherford categories 4-6.
4. Candidate for both endovascular and open infrainguinal revascularization as judged by
the treating investigators
5. Adequate aortoiliac inflow.
6. Adequate popliteal, tibial or pedal revascularization target defined as an
infrainguinal arterial segment distal to the area of stenosis/occlusion which can
support a distal anastomosis of a surgical bypass.
7. Willingness to comply with protocol, attend follow-up appointments, complete all study
assessments, and provide written informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Presence of a popliteal aneurysm (>2 cm) in the index limb.
2. Life expectancy of less than 2 years due to reasons other than PAOD.
3. Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI
Team)
4. Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
5. Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
6. Any prior index limb infrainguinal stenting or stent grafting associated with
significant restenosis within 1 cm of stent or stent-graft, unless the
occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial
vessel that is not currently intended to be revascularized as a part of the treatment
for CLI).
7. Any of the following procedures performed on the index limb within 3 months prior to
enrollment:
1. Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
2. Infrainguinal bypass with either venous or prosthetic conduit
8. Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral,
thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment
9. Current chemotherapy or radiation therapy.
10. Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid
reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) which
would preclude patient participation in angiographic procedures.
11. Pregnancy or lactation.
12. Administration of an investigational drug for PAD within 30 days of randomization.
13. Participation in a clinical trial (except observational studies) within the previous
30 days.
14. Prior enrollment or randomization into BEST-CLI.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2022
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Sample size
Target
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Accrual to date
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Final
1843
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
California
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Colorado
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Connecticut
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Country [7]
0
0
United States of America
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State/province [7]
0
0
District of Columbia
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Florida
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Georgia
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Hawaii
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Illinois
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Indiana
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Iowa
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Louisiana
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Maine
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Maryland
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Massachusetts
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Michigan
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Minnesota
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Missouri
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Country [21]
0
0
United States of America
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State/province [21]
0
0
Nebraska
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Country [22]
0
0
United States of America
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State/province [22]
0
0
New Hampshire
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Country [23]
0
0
United States of America
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State/province [23]
0
0
New Jersey
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Country [24]
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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United States of America
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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Finland
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Helsinki
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Italy
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Florence
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New Zealand
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Auckland
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Waikato
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New Zealand
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Carelon Research
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Brigham and Women's Hospital
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0
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Other
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Massachusetts General Hospital
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Other
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Name [3]
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Boston Medical Center
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Government body
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National Heart, Lung, and Blood Institute (NHLBI)
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Commercial sector/Industry
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Abbott
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Commercial sector/Industry
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Bard Ltd
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Commercial sector/Industry
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Boston Scientific Corporation
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Commercial sector/Industry
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Cordis Corporation
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Commercial sector/Industry
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Abbott Medical Devices
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Other
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Name [10]
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Canadian Society for Vascular Surgery
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Address [10]
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0
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0
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Other collaborator category [11]
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Other
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Name [11]
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Eastern Vascular Society
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Address [11]
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Other collaborator category [12]
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Commercial sector/Industry
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Name [12]
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W.L.Gore & Associates
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Other
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Name [13]
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Midwest Vascular Society
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Other
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Name [14]
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New England Society for Vascular Surgery
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Other
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Name [15]
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Society for Clinical Vascular Surgery
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Other
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Society for Interventional Radiology
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Other
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Southern Vascular Society
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Other
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Name [18]
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Society for Vascular Medicine
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Other
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Society for Vascular Surgery
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Other
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Vascular and Endovascular Surgery Society
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Other
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Vascular Interventional Advances
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Other
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Western Vascular Society
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Address [22]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will compare the effectiveness of best available surgical treatment with best
available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible
for both treatment options.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02060630
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Matthew Menard, MD
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Address
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Brigham and Women's Hospital
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02060630
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