JPRN-UMIN000033656已完成3 期
A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia - The SAVAL Pivotal Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
研究概览
简要总结
A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 +- 35.2 mm for the DES group and 68.7 +- 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Pre-procedure: 1. Life expectancy <= 1year 2. Stroke <= 90 days prior to the procedure date 3. Prior or planned major amputation in the target limb 4. Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass) 5. Previously implanted stent in the target vessel(s) 6. Failed PTA of target lesion/vessel <= 60 days prior to the procedure date 7. Renal failure as measured by a GFR <= 30ml/min per 1.73m^2, measured <= 30 days prior to the procedure date 8. Subject has a platelet count <= 50 or => 600 X 10^3/uL <= 30 days prior to the procedure date 9. NYHA class IV heart failure 10. Subject has symptomatic coronary artery disease (ie, unstable angina) 11. History of myocardial infarction or thrombolysis <= 90 days prior to the procedure date 12. Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis) 13. Subject is currently taking Canagliflozin 14. Body Mass Index (BMI) <18 15. Active septicemia or bacteremia 16. Coagulation disorder, including hypercoagulability 17. Contraindication to anticoagulation or antiplatelet therapy 18. Known allergies to stent or stent components 19. Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure 20. Known hypersensitivity to heparin 21. Subject is on a high dose of steroids or is on immunosuppressive therapy 22. Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial Intra-procedure: 1. Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism 2. Treatment required in > 2 target vessels 3. Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy) 4. Aneurysm is present in the target vessel(s) 5. Extremely calcified lesions
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