NCT03477604进行中（未招募）不适用
A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
Micro Medical Solution, Inc.41 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2020年3月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 177
- 试验地点
- 41
- 主要终点
- Freedom from perioperative death
研究概览
简要总结
Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria:
- •Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old.
- •Subject has documented clinical evidence of critical limb ischemia (CLI) in the target limb prior to the index procedure, with a Rutherford Classification score of 4-
- •The subject, or subject's designated legal representative, has been informed of the nature of the study and is willing to provide written informed consent.
- •Subject is willing to comply with all required follow-up visits.
- •Subject life expectancy is ≥1 year per the Principal Investigator.
- •Angiographic Inclusion Criteria
- •Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (<50% stenosis) inframalleolar outflow vessel.
- •Subject has a lesion, with ≥ 70% stenosis and ≤ 12.0 cm in length located at or distal to the tibial-peroneal trunk and above the tibiotalar joint; including the anterior tibial, posterior tibial or peroneal arteries.
- •Target lesion has a reference vessel diameter of 2.5 - 4.5 mm
- •The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.
排除标准
- •Subject had a prior or has a planned index limb amputation above the ankle.
- •Subject has a wound/ulcer on the forefoot with a surface area >4cm² or osteomyelitis involving the calcaneus bone.
- •Subject is pregnant, plans to become pregnant, or is nursing.
- •Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).
- •Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.
- •Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.
- •Subject is in acute renal failure.
- •Subject has an active systemic infection.
- •Subject is participating in another research study involving an investigational device, biologic, or drug that has not completed the primary endpoint at the time of randomization/enrollment.
- •Subject has other comorbidities that - in the opinion of the investigator - preclude them from receiving study treatment and/or from completing the required study follow-up assessments.
- •Subject presents with acute limb ischemia or acute thrombosis of the target limb.
- •Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.
- •Subject had a stroke within 3 months of index procedure.
- •Angiographic exclusion criteria
- •Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g embolism).
- •Failure to successfully treat significant non-target infra-popliteal lesions. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g. embolism).
- •Target lesion is within a previously placed stent.
研究组 & 干预措施
MicroStent and Standard PTA
Experimental
Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.
干预措施: MicroStent and Standard PTA (Device)
Standard PTA
Active Comparator
干预措施: Standard PTA (Device)
结局指标
主要结局
Freedom from perioperative death
时间窗: up to 30 days after randomization
Freedom from perioperative death
Freedom from major adverse limb event
时间窗: up to 6 months after randomization
Freedom from major adverse limb event
Patency of the target lesion
时间窗: up to 6 months after randomization
Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation.
次要结局
- Freedom from major amputation above the ankle(up to 6 months after randomization)
- Reduction in size of ischemic leg/foot ulcers(up to 6 months after randomization)
- Frequency and severity of serious adverse events and device and procedure related adverse events(From date of randomization until the date of death from any cause assessed up to 36 months)
- Freedom from major adverse limb event(From date of randomization until the date of death from any cause assessed up to 36 months)
研究者
研究点 (41)
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