DRKS00004546已完成未知
Randomized Evaluation of the Zilver® PTX® Stent vs Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery - REAL PTX
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 150
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
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Subject age = 18
- •2. Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
- •3. Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
- •4. Rutherford category 2-5.
- •5. Subject has a de novo or restenotic lesion with = 70% stenosis documented angiographically and no prior stent in the target lesion.
- •6.Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
- •7. A single target lesion (stenotic areas separated by more than 3 cm with = 30% stenosis might, at the decision of the investigator, be considered as 2 lesions).
- •8. Reference vessel diameter (RVD) = 4 mm and = 6.5 mm by visual assessment.
- •9. Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
- •10. A guidewire has successfully traversed the target treatment segment.
排除标准
- •Clinical exclusion criteria
- •1. Inability to obtain informed consent.
- •2. Life expectancy < 12 months.
- •3. Pregnancy, suspected pregnancy, or breastfeeding during study period (patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment).
- •4. Presence of one or more of the following co-morbid factors: hemodialysis dependence, renal insufficiency with a serum creatinine = 2.5 mg/dl, cerebrovascular accident (CVA) within 1 month of procedure or any CVA resulting in unresolved walking impairment, and/or myocardial infarction (MI) within 1 month of procedure.
- •5. Any evidence of hemodynamic instability prior to procedure/randomization.
- •6. Coagulopathy or clotting disorders.
- •7. Present or suspected systemic infection or osteomyelitis affecting target limb.
- •8. Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc).
- •9. Hypersensitivity to nitinol and/or paclitaxel.
- •10. Enrollment into another study.
- •11. Intervention of the target lesion less than 90 days prior of the study procedure.
- •Anatomic Exclusion Criteria:
- •1. Untreated external iliac artery inflow lesion (study allows for successful treatment prior to study treatment procedures).
- •2. Total occlusion uncrossable by a conventional guidewire.
- •3. Acute occlusive intraluminal thrombosis of the proposed lesion site.
- •4. Evidence of an aneurysm at the target lesion site.
- •5. Perforation in the target vessel as evidenced by the extravasation of contrast.
研究者
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