JPRN-jRCT1090220313已完成3 期
Prospective, multicenter, single-arm clinical trial to value the safety and efficacy of Rotablator atherectomy system as an adjunctive device for the endovascular treatment of occlusive atherosclerotic lesions in the below the knee with critical limb ischemia. - RESCUE BTK trial
RESCUE Clinical Trial Office0 个研究点目标入组 17 人开始时间: 2017年10月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Provisional registration
- •1. Rutherford category 4 or 5 due to atherosclerotic peripheral artery disease.
- •2. SPP less than 50mmHg below ankle joint.
- •3. Presence of one or more risk factors as follows:
- •Diabetes, maintenance dialysis (hemodialysis or peritoneal dialysis), renal failure (eGFR less than 60ml/min/1.73m2), age 65 years or more, presence of calcification in below-the-knee arteries.
- •4. Age 20 years or more at the time of informed consent.
- •5. Agreement for participating in the study and written informed consent provided by the patients or legally acceptable representative.
- •2) Definitive registration
- •1. Unsuccessful balloon angioplasty for target lesion within 2 weeks prior to the definitive registration.
- •2. Presence of calcification in the target lesion.
- •3. Target lesion between the distal popliteal artery and the distal crural artery.
- •4. Target lesion with visual reference vessel diameter 2.0 to 4.0 mm.
- •5. Target lesion length less than 100mm.
排除标准
- •1) Provisional registration
- •1. Inability to receive contract agents.
- •2. History of amputation above knee joint, or planning major amputation surgery of the target lower limb.
- •3. Prior bypass surgery to the target lower limb
- •4. Prior stent implantation in target vessel.
- •5. Prior endovascular intervention to the non-target vessel of the target lower limb within 1 week prior to provisional registration.
- •6. Prior enrollment of this trial .
- •7. Patients with severe wound inflammation or with any severe infectious disease.
- •8. History of myocardial infarction, ischemic stroke, intracranial hemorrhage within 6 months prior to provisional registration.
- •9. Non-dialysis patient with serum creatinine level 2.0 mg/dL or more.
- •10. Any abnormal blood test: Platelet count less than 80,000 /uL or 600,000 /uL or more, white blood cell less than 3,000 /uL, or hemoglobin less than 8.0 g/dL.
- •11. Inability to move by wheelchair.
- •12. Life expectancy of less than 1 year.
- •13. Pregnant, breastfeeding or possibly pregnant women.
- •14. Contraindication to antiplatelet medications.
- •15. Participating or planning to participate in other clinical trials or interventional studies.
- •16. Any other reason, based on the investigator's discretion.
- •2) Definitive registration
- •1. Failed target lesion passage of guidewire.
- •2. Angiographic thrombus.
- •3. High risk for arterial perforation by trial procedures based on the investigator's discretion.
- •4. Prior endovascular intervention to non-target vessel of the target lower limb within 1 week prior to definitive registration.
- •5. Prior enrollment of this trial.
- •6. Any other reason based the investigator's discretion.
研究者
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