DRKS00000253已完成4 期
Evaluation of Efficacy and Safety of the FlexStent Femoropopliteal Self-Expanding Stent System Study -The Flexstent-Registry
Park-Krankenhaus Leipzig,Zentrum für Gefäßmedizin,Klinik f. Innere Medizin I/ Angiologie, Kardiologie0 个研究点目标入组 100 人开始时间: 2010年1月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 35 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. Subjects, male or female, must be between the ages of 35 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.
- •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 femoro/popliteal artery
- •5. Disease segment length <=150mm
- •6. >70% 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 3.5-7.5 mm
排除标准
- •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 > 2.5 mg/dL.
- •7. Myocardial infarction or stroke within 90 days of enrollment.
- •8. Hypercoagulable state.
- •9. Uncontrollable hypertension.
- •10. Patients currently enrolled in any other clinical trial(s).
研究者
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