The SUMMIT -RegistryEvaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System
- Conditions
- I73.9Peripheral vascular disease, unspecified
- Registration Number
- DRKS00003090
- Lead Sponsor
- Provascular GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Subjects, male or female, must be between the ages of 18 to 85 years inclusive at the time of consent.
- A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening.
- Subjects must give written informed consent prior to participation in the study
- Rutherford Classification Category 2-4
- Single de novo lesion in the superficial femoro/popliteal artery
- Disease segment length =150mm
->70% diameter stenosis and occlusion
- Patent ipsilateral iliac artery
- Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle
- Target reference vessel diameter 3.5-7.5 mm
- Target lesion previously treated with a stent or surgery
- Rutherford Classification Category 0, 1, 5 or 6
- Inability to tolerate antithrombotic or antiplatelet therapies
- Pregnancy
Other co morbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up
- Serum creatinine > 2.5 mg/dL
- Myocardial infarction or stroke within 90 days of enrollment
Hypercoagulable state
- Uncontrollable hypertension
- Patients currently enrolled in any other clinical trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy of the EPIC™ Stent as measured by in-stent binary restenosis using DUS at 6 and 12 months after procedure<br>Binary restenosis is defined as a peak systolic velocity ratio (PSVR) =2.5:1<br><br>
- Secondary Outcome Measures
Name Time Method technical success defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%<br>after stent placement intra-procedural via angiographic images
Related Research Topics
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