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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01442636
Registration number
NCT01442636
Ethics application status
Date submitted
22/09/2011
Date registered
28/09/2011
Date last updated
9/03/2015
Titles & IDs
Public title
Drug Eluting Stents In The Critically Ischemic Lower Leg 2
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Scientific title
a Prospective, Multicenter, Controlled Trial Evaluating the Implant of a Drug Eluting Stent (XIENCE PRIME, Abbott Vascular) in the Critically Ischemic Lower Leg
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Secondary ID [1]
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FMRP-101021
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Universal Trial Number (UTN)
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Trial acronym
DESTINY 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease
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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - stent
Experimental: Xience Prime stent - Patients with critical limb ischemia due to below the knee arterial lesion between 30 and 100mm in length, treated with the XIENCE PRIME™ Everolimus Eluting Coronary Stent System.
Treatment: Devices: stent
Implantation of one or more Everolimus-eluting XIENCE PRIME™ Everolimus Eluting Coronary Stent Systems.
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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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Primary patency at 12 months
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Assessment method [1]
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Absence of restenosis (=50% stenosis) or occlusion within the originally treated lesion based on angiography
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Technical success
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Assessment method [1]
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The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
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Timepoint [1]
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procedure
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Secondary outcome [2]
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Hemodynamic primary patency rate at 1, 6, 12-month follow-up
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Assessment method [2]
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Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up.
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Timepoint [2]
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1, 6, 12-month follow-up
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Secondary outcome [3]
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Limb-salvage rate at all follow-up visits
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Assessment method [3]
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Absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot).
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Timepoint [3]
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1, 6, 12-month follow-up
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Secondary outcome [4]
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Primary assisted patency rate at 1, 6, 12-month follow-up
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Assessment method [4]
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Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
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Timepoint [4]
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1, 6, 12-month follow-up
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Secondary outcome [5]
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Secondary patency rate at 1, 6, 12-month follow-up
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Assessment method [5]
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Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
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Timepoint [5]
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1, 6, 12-month follow-up
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Secondary outcome [6]
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Target lesion revascularization (TLR) at all follow-up visits
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Assessment method [6]
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A repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.
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Timepoint [6]
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1, 6, 12-month follow-up
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Secondary outcome [7]
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Clinical success at all follow-up visits
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Assessment method [7]
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An improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
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Timepoint [7]
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1, 6, 12-month
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Secondary outcome [8]
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Serious adverse events until follow-up completions
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Assessment method [8]
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Any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
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Timepoint [8]
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1,6,12 months and interim visits
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Eligibility
Key inclusion criteria
* Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient is >18 years old
* Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* Patient has a projected life-expectancy of at least 12 months
* Patient is eligible for treatment with the XIENCE PRIME stent (Abbott Vascular)
* Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
Angiographic
* De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
* Total target lesion length minimally 30mm and maximally 100mm
* Target vessel diameter visually estimated to be >2.0mm and <3.5mm
* Guidewire and delivery system successfully traversed lesion
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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
* Patient refusing treatment
* The reference segment diameter is not suitable for the available stent design
* Untreated flow-limiting inflow lesions
* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
* Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
* Aneurysm in the target vessel
* Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
* Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
* Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
* Septicemia or bacteremia
* Any previously known coagulation disorder, including hypercoagulability
* Contraindication to anticoagulation or antiplatelet therapy
* Known allergies to stent or stent components
* Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
* Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
* Currently participating in another clinical research trial
* Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
* Target lesion access not performed by transfemoral approach.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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Other design features
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Phase
Phase 2
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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
1/07/2011
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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
1/11/2014
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Sample size
Target
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Accrual to date
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Final
60
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Prince of Wales Private Hospital - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Antwerp
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Country [2]
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Belgium
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State/province [2]
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East-Flanders
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Country [3]
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Germany
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State/province [3]
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Bad Krozingen
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Country [4]
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Germany
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State/province [4]
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Leipzig
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Country [5]
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Germany
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State/province [5]
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Münster
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Funding & Sponsors
Primary sponsor type
Other
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Name
Flanders Medical Research Program
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this clinical evaluation is to evaluate the immediate and long term (up to 12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott Vascular) in a controlled prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries. Specifically the trial aims to illicit angiographic and ultrasound patency, clinical improvement, and adverse events associated with the use of this stent. The trial design is single armed, prospective, controlled trial run over 12 months of follow-up.
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Trial website
https://clinicaltrials.gov/study/NCT01442636
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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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Marc Bosiers, MD
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Address
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A.Z. Sint-Blasius Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01442636
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