Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 13
- 主要终点
- Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%)
研究概览
简要总结
Prospective, multicenter, randomized clinical trial, Follow-up at 1-, 6- and 12 months
This clinical investigation is first of all designed to demonstrate the safety and effectiveness of the MAGIC EXPLORER stent system. The primary objectives of the study are to evaluate the safety and 6-month patency of the bioabsorbable MAGIC EXPLORER stent in patients with stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries. Secondary endpoints are the procedural success, patency at all follow-ups, late lumen loss and limb-salvage rate. Peri-procedural complications (within 24 hours) will be evaluated. Furthermore, data of the balloon catheter PLEON EXPLORER will be collected to demonstrate its effectiveness and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stenotic (> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
- •Length of lesion < 20mm (less than one stent length)
- •Reference vessel diameter should be 3.0-3.5 mm
- •A maximum of two lesions in one infrapopliteal vessel treated within the study, or in two vessels of two different legs. (PTA treatment of other infrapopliteal lesions in non-study vessels is allowed outside the study).
- •Symptomatic critical limb ischemia (Rutherford 4, 5)
- •The patient must be ≥ 50 years.
- •Life-expectancy of more than 6 months
- •The subject or legal guardian has been informed of the nature of the study; agrees to its provisions and has signed informed consent
- •The patient must be available for the appropriate follow-up times for the duration of the study
- •The patient is capable to follow all study requirements.
排除标准
- •Patient refusing treatment
- •The reference segment diameter is not suitable for available stent design
- •Length of lesion requires more than one stent implantation
- •Previously implanted stent(s) or PTA at the same lesion site
- •Lesion lies within or adjacent to an aneurysm
- •Inflow-limiting arterial lesions left untreated
- •The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
- •The patient takes Phenprocoumon (Marcumar).
- •The patient has a history of prior life-threatening contrast media reaction.
- •The patient is currently enrolled in another investigational device or drug trial.
- •The patient is currently breast-feeding, pregnant or intends to become pregnant.
- •The patient is mentally ill or retarded.
- •The patient is liable for military or civilian service.
结局指标
主要结局
Efficacy : patency of the AMS, defined as the absence of a hemodynamically significant restenosis (> 50%)
时间窗: 6 month
Safety: Complications at 1 month post-procedure (major amputations or any cause of death)
时间窗: 1 month
次要结局
- Limb-salvage rate at follow-up visits, defined as lack of major amputation.(1 & 6 months)
- Patency at follow-up visits determined with Color Flow Doppler Ultrasound (CFDU)(1 & 6 months)
- Immediate angiographic procedural success, defined as maximal 30% residual stenosis on visual assessment of the planned treatment area.(procedure)
- Late lumen loss at 6 months.(6 months)