NCT06539689招募中不适用
A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of Sperstent® Peripheral Spot Stent System Used for the Residual Lesions After Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries
FrontAce Scientific Co., Ltd12 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年6月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- Freedom from Major Adverse Events (MAEs)
研究概览
简要总结
This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and/or dissections in femoral and proximal popliteal arteries.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years old, male or female;
- •The target lesion is located in the superficial femoral artery or the proximal popliteal artery;
- •Peripheral arterial stenosis or occlusive disease with symptoms consistent with the Rutherford classification 2 to 5;
- •Estimated life expectancy >1 year;
- •Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.
- •Angiographic Inclusion Criteria:
- •Stenosis rate ≥70% under DSA by visual estimate, or 100% occluded lesion with a total lesion length less than 150mm (by visual estimate);
- •Reference vessel diameter is between 3 mm and 7.5 mm, 50mm≤Total cumulative length of target lesions≤250mm; (In the case of bilimb lesions, a single target lesion with one limb meeting the protocol criteria is selected by the investigator; More than 2cm between lesions are considered as 2 lesions);
- •After PTA treatment by DCB, there exists residual lesions, such as the target lesion has over 30% residual DS and/or presence of at least one post-PTA dissection (Type A-F) (by visual estimate);
- •Patients with unobstructed inflow tract or successfully treated, visual residual stenosis ≤50%;
- •Angiography showed at least one outflow tract was unobstructed at the distal end (Stenosis degree ≤70% before intervention).
排除标准
- •Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;
- •Patients with serum creatinine >2.5mg/dl during screening or undergoing long-term hemodialysis or peritoneal dialysis;
- •Severe coagulation disorder;
- •Patients with major vascular-related diseases, including acute lower extremity ischemia, active disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, and aneurysms of therapeutic lateral vessels (deep femur, superficial femur, or popliteal artery);
- •A history of major organ failure or other serious illness (including severe coronary heart disease, severe cardiac insufficiency, severe neurosis, or mental illness); Have received or plan organ transplantation, severe gastrointestinal bleeding);
- •Myocardial infarction or symptomatic stroke occurred within 3 months prior to enrollment;
- •Thrombolysis of target vessel within 72 hours before surgery, did not completely dissolve the thrombus;
- •Systemic infection or uncontrolled infection within the target limb;
- •Known allergy to contrast agents, nickel or titanium (Nitinol), heparin, aspirin, clopidogrel, anesthetics;
- •Women who are pregnant or breast-feeding, or women of childbearing age who have family plans within 1 year;
- •Patients who are planning to have major lower limb amputations on the target side of the lesion;
- •Endovascular or surgical procedures are performed on the target limb within 30 days before or 30 days after surgery;
- •Participating in clinical trials of other medical devices or drugs;
- •The investigator considers the patient is not suitable for participation in the clinical trial.
- •Angiographic Exclusion Criteria:
- •Failure of the guidewire to pass through the lesion；
- •During the procedure, the target lesions had received or were scheduled to receive volume reduction procedures such as cryogenic angioplasty, laser angioplasty, and percutaneous intracavity plaque gyrotomy；
- •The target lesion before stent implantation is thrombotic obliteration, which is not suitable for stent implantation；
- •The target lesions were severely calcified and could not fully predilate; Or grade 4 calcification；
- •Acute vascular occlusion or acute or subacute thrombosis in the target lesion；
- •Stent was implanted into the target vessel before enrollment.
结局指标
主要结局
Freedom from Major Adverse Events (MAEs)
时间窗: 30 days post-operation
Freedom from the occurrence of any new-onset MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) at 30 days post-operation.
Primary Patency
时间窗: 12 months post-operation
Primary patency defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 12 months post-operation.(defined as PSVR \>2.5)
次要结局
- Duplex Ultrasound (DUS) Derived Lesion Patency(30 days, 6 months and 12 months post-operation)
- Rate of clinically driven target lesion revascularization (CD-TLR)(30 days, 6 months and 12 months post-operation)
- Rate of major adverse event(s) (MAEs)(6 months and 12 months post-operation)
- Rate of Device Success(immediately post-operation)
- Rate of Procedural Success(immediately post-operation)
- Primary Patency at 30 days and 6 months(30 days and 6 months post-operation)
- Changes from Baseline in Rutherford Classification(30 days, 6 months and 12 months post-operation)
- Changes from Baseline in Ankle-brachial Index (ABI)(30 days, 6 months and 12 months post-operation)
- Rate of Stent Fracture(12 months post-operation)
研究者
研究点 (12)
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