Status:
COMPLETED
DURABILITY™ Iliac Study
Lead Sponsor:
Medtronic Endovascular
Conditions:
Peripheral Arterial Disease
Claudication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™ Self-Expanding Stent ...
Eligibility Criteria
Inclusion
- Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4.
- Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
- Willing to comply with all follow-up evaluations at the specified times.
- Provides written informed consent prior to enrollment in the study.
Exclusion
- Previous implantation of stent(s) in the target vessel.
- Received endovascular treatment of the target lesion within six months prior to the index procedure.
- Known hypersensitivity to contrast material that cannot be adequately pretreated.
- Known hypersensitivity to nickel-titanium.
- Life expectancy of less than 12 months
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01400919
Start Date
July 1 2011
End Date
January 1 2016
Last Update
March 7 2018
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029