The SUMMIT -RegistryEvaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System - SUMMIT

Provascular GmbH0 个研究点目标入组 100 人开始时间: 2011年5月25日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

发起方