N/A
N=75
DURABILITY™ Iliac Study
Peripheral Arterial Disease · Claudication
Bottom Line
View on ClinicalTrials.gov: NCT01400919 ↗Enrolled (actual)
75
Serious AEs
38.7%
Results posted
Jun 2015
Primary outcome: Primary: Major Adverse Event Rate — 1.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Event Rate |
1.3 | — |
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 Systems for the treatment of atherosclerotic lesions in the common and/or external iliac arteries.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01400919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.