Evaluation of Safety and Efficacy of the Flexstent Peripheral Stent System in a First in Man Study in patients with superficial femoral artery diseae.

Flexible Stenting Solutions Inc0 个研究点目标入组 10 人开始时间: 2008年5月13日最近更新: 2020年1月13日

试验速览

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•1.Subjects, male or female, must be between the ages of 35 to 80 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening.
•2.Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.
•3.Rutherford Classification Category 2-4
•4.Single de novo lesion in the superficial femoral artery
•5.Disease segment length =100mm
•6.>50% diameter stenosis and occlusion
•7.Patent ipsilateral iliac artery
•8.Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle
•9.Target reference vessel diameter 3.5-5.5 mm

•1.Target lesion previously treated with a stent or surgery
•2.Rutherford Classification Category 0,1,5 or 6
•3.Inability to tolerate antithrombotic or antiplatelet therapies
•4.Pregnancy
•5.Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
•6.Serum creatinine >180 mmol/l
•7.Myocardial infarction or stroke within 90 days of enrollment
•8.Hypercoagulable state
•9.Uncontrollable hypertension

发起方

Flexible Stenting Solutions Inc