DURABILITY™ Iliac Study
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | July 2011 |
| End Date: | January 2016 |
Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)
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.
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.
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
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