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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/NCT03041467
Registration number
NCT03041467
Ethics application status
Date submitted
1/02/2017
Date registered
2/02/2017
Date last updated
29/05/2024
Titles & IDs
Public title
IN.PACT™ AV Access IDE Study
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Scientific title
Randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
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Secondary ID [1]
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APV-IN.PACT AV Access
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arteriovenous Fistula Stenosis
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Arteriovenous Fistula Occlusion
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Arteriovenous Fistula
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Fistula
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - IN.PACT AV DCB
Treatment: Devices - Standard Balloon Angioplasty
Experimental: IN.PACT AV DCB - PTA will be performed using the IN.PACT AV Access Drug Coated Balloon. IN.PACT AV Access DCB was the device name used during the clinical study. Medtronic has changed the name of the device to IN.PACT™ AV Paclitaxel-Coated Balloon Catheter (also referred as IN.PACT AV DCB). Hence, throughout posting, the study device will be referred to as the "IN.PACT AV DCB."
Active Comparator: Standard Balloon Angioplasty - PTA will be performed using a commercially available uncoated PTA balloon.
Treatment: Devices: IN.PACT AV DCB
IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
Treatment: Devices: Standard Balloon Angioplasty
Standard PTA Balloon
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Intervention code [1]
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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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Target Lesion Primary Patency Rate Through 6 Months
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Assessment method [1]
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Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
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Timepoint [1]
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6 Months Post-Procedure
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Primary outcome [2]
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Primary Safety Endpoint - Serious Adverse Event Rate
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Assessment method [2]
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Serious Adverse Event (SAE) rate involving the AV access circuit
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Timepoint [2]
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30 days post procedure
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Secondary outcome [1]
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Access Circuit Primary Patency
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Assessment method [1]
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Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
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Timepoint [1]
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3, 6, 9, 12, 18, and 24 Months
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Secondary outcome [2]
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Target Lesion Primary Patency
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Assessment method [2]
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Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.
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Timepoint [2]
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3, 9, 12, 18, and 24 Months
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Secondary outcome [3]
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Cumulative Target Lesion Revascularizations
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Assessment method [3]
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The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
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Timepoint [3]
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3, 6, 9,12, 18, and 24 Months
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Secondary outcome [4]
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Total Number of Interventions Required to Maintain Target Lesion Patency
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Assessment method [4]
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The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure.
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Timepoint [4]
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3, 6, 9, 12, 18, and 24 Months
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Secondary outcome [5]
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Total Number of Interventions Required to Maintain Access Circuit Patency
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Assessment method [5]
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The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.
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Timepoint [5]
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3, 6, 9, 12, 18, and 24 Months
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Secondary outcome [6]
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Cumulative Access Circuit Thromboses
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Assessment method [6]
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The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
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Timepoint [6]
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3, 6, 9, 12, 18, and 24 Months
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Secondary outcome [7]
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Device Success
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Assessment method [7]
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Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.
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Timepoint [7]
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Time of Procedure
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Secondary outcome [8]
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Procedure Success
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Assessment method [8]
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Maintenance of patency (=30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
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Timepoint [8]
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Time of Procedure
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Secondary outcome [9]
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Clinical Success
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Assessment method [9]
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Resumption of successful dialysis for at least one session after index procedure.
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Timepoint [9]
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From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
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Secondary outcome [10]
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Rate of Device Related Adverse Events
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Assessment method [10]
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Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
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Timepoint [10]
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30 days, 3, 6, 9, 12, 18, and 24 Months.
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Secondary outcome [11]
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Procedure Related Adverse Event Rate
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Assessment method [11]
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Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
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Timepoint [11]
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30 Days, 3, 6, 9, 12, 18, and 24 Months
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Secondary outcome [12]
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Target Lesion Revascularizations (TLR)
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Assessment method [12]
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Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
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Timepoint [12]
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6, 9, 12, 18, 24, and 36 Months
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Secondary outcome [13]
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Clinically-Driven Target Lesion Revascularizations (CD-TLR)
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Assessment method [13]
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Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure
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Timepoint [13]
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6, 9, 12, 18, 24, and 36 Months
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Secondary outcome [14]
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Re-interventions in the Access Circuit
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Assessment method [14]
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Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
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Timepoint [14]
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6, 9, 12, 18, 24, and 36 Months
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Secondary outcome [15]
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Abandonment of Target AVF
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Assessment method [15]
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Defined as number of participants with abandonment of the target AV up to 36 months post-index procedure.
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Timepoint [15]
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6, 9, 12, 18, 24, and 36 Months
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Secondary outcome [16]
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Serious Adverse Event Rate
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Assessment method [16]
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Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.
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Timepoint [16]
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6, 12, 24, and 36 Months
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Secondary outcome [17]
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Rate of Freedom From All-Cause Mortality Post Vital Status Update
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Assessment method [17]
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Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months.
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Timepoint [17]
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6, 12, 24, 36, 48, and 60 Months
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Eligibility
Key inclusion criteria
1. Patient is =21 years of age.
2. Patient has a life expectancy of = 12 months
3. Patient has a native AV fistula created = 60 days prior to the index procedure
4. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions
during a four week period
5. Patient has a de novo and/or non-stented restenotic lesion located between the
arteriovenous anastomosis and axillosubclavian junction with =50% stenosis. Note: If
the lesion is located in the anastomosis, the treatment may be delivered up to 2 cm
upstream on the arterial side. If the lesion is located in the cephalic arch, the
treatment may be delivered up to 2 cm into the subclavian vein
6. Patient has a target lesion or a tandem lesion that is = 100 mm in length (by visual
estimate) Note: Tandem lesions may be enrolled provided they meet all of the following
criteria: Separated by a gap of = 30mm (3 cm), total combined lesion length, including
30 mm gap, = 100 mm, and able to be treated as a single lesion
7. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate).
8. Patient underwent successful crossing of the target lesion with the guide wire and
pre-dilatation with a high pressure PTA balloon defined as: residual stenosis of = 30%
and absence of a flow limiting dissection (Grade = C) or perforation
9. Patient provides written consent prior to enrollment in the study
10. Patient is willing to comply with all follow-up evaluations at specified times
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Minimum age
21
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. Women who are breastfeeding, pregnant, or are intending to become pregnant, or men
intending to father children
2. Patient is receiving immunosuppressive therapy
3. Patient is anticipating a kidney transplant within 6 months of enrollment into the
study
4. Patient has undergone prior intervention of access site within 30 days of index
procedure
5. Patient with anticipated conversion to peritoneal dialysis
6. Patient has an infected AV access or systemic infection
7. Patient has planned surgical revision of access site
8. Patient with secondary non-target lesion requiring treatment within 30-days post index
procedure
9. Patient with hemodynamically significant central venous stenoses that cannot be
successfully treated prior to treatment of the target lesion
10. Patient with target AVF or access circuit which previously had or currently has a
thrombosis
11. Patients judged to have a lesion that prevents complete inflation of an angioplasty
balloon or proper placement of the delivery system
12. Patient with target lesion located central to the axillosubclavian junction
13. Patient has significant arterial inflow lesion requiring treatment more than 2 cm
upstream from the anastomosis in the AV access
14. Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion
site
15. Patient has presence of a stent located in the target AV access circuit
16. Patients with known allergies or sensitivities to paclitaxel
17. Patient with known contraindication, including allergic reaction, or sensitivity to
contrast material that cannot be adequately pre-treated
18. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
19. Patient with clinically significant Steal Syndrome requiring treatment
20. Patient is enrolled in another investigational drug, device, or biological study and
has not completed the primary endpoint, or was previously enrolled in this study
21. Patient has a comorbid-condition that, in the judgment of the Investigator, may cause
him/her to be non-compliant with the protocol of confound data interpretation
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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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
25/04/2017
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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
5/05/2023
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Sample size
Target
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Accrual to date
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Final
330
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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United States of America
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California
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United States of America
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Florida
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Illinois
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Iowa
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Kentucky
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Minnesota
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New Jersey
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New York
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North Carolina
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Ohio
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South Dakota
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Tennessee
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Texas
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Virginia
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Japan
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Amagasaki
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Japan
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Kamakura
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Japan
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Kishiwada
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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New Zealand
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Auckland
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New Zealand
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic Endovascular
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB)
compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting
with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis
fistulae (AVF) in the upper extremity.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03041467
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert Lookstein, MD
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Address
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The Mount Sinai Hospital
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03041467
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