NCT06211127招募中不适用
Assessment the Safety and Efficacy of Cold Laser Plaque Ablation for Lower Limb Arterial Stenosis and Occlusive Lesions: A Prospective, Multicenter, Randomized Controlled Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- residual diameter stenosis
研究概览
简要总结
This study is a prospective, multi-center, randomized controlled study, which evaluates the effectiveness and safety of cold laser plaque ablation for lower limb arterial stenosis and occlusive lesions from intermittent claudication to chronic threatening limb ischemia.
详细描述
This study is a prospective, multi-center, randomized controlled study. This study will be conducted at four centers and is expected to enroll 110 patients. And we will evaluate the effectiveness and safety of cold laser plaque ablation compared to excimer laser system for lower limb arterial stenosis and occlusive lesions.
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
- •General selection criteria
- •Age between 18 and 85, gender is not limited;
- •Patients with symptomatic lower extremity arteriosclerosis disease (LEAD), Rutherford grade 2 to 5;
- •The stenosis of lower extremity arteries is greater than 70% or occlusion;
- •The subject is able and willing to comply with all requirements, including 6-month follow-up and evaluation, voluntary participation and informed consent.
- •Intraoperative contrast inclusion criteria
- •The internal diameter of the reference vessel proximal to the target lesion is greater than 1.8mm;
- •The stenosis of target lesion is greater than 70%;
排除标准
- •The target lesion is located in the artificial vascular or autologous venous vascular bypass;
- •Endovascular or surgical procedure in the target limb performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure;
- •Intent to use other atherectomy device in the same procedure;
- •Flow-limiting dissection within, proximal or distal to the target lesion;
- •Evidence or history of aneurysm in the target vessel， intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
- •Uncorrected coagulation abnormalities (platelet count ≤ 75*109/ L or INR≥2.0), bleeding constitution, and history of heparin-induced thrombocytopenia (HIT);
- •Any thrombolytic therapy was performed within 2 weeks before surgery;
- •History of severe trauma, fracture, major surgery, or parenchymal organ biopsy within 2 weeks before surgery;
- •Known allergy to contrast agents or perioperative drugs;
- •Anticoagulation, antiplatelet or thrombolytic therapy is prohibited;
- •Pregnant or lactating women;
- •Subjects participating in other clinical trials of drugs or medical devices;
- •Other circumstances assessed by the investigator as inappropriate to participate in the trial.
结局指标
主要结局
residual diameter stenosis
时间窗: 1 month, 6 months after surgery
Reduction from baseline in residual diameter stenosis (measured in percent), prior to any adjunctive therapy, achieved by the laser catheter, as assessed quantitatively by the core laboratory based upon the procedure angiograms.
次要结局
- Secondary effectiveness evaluating indicator:1）Primary patency rate(1 month, 6 months after surgery)
- Secondary effectiveness evaluating indicator:2）Revascularization rate of target vessels(1 month, 6 months after surgery)
- Secondary effectiveness evaluating indicator:4）Ankle-brachial index(1 month, 6 months after surgery)
- safety evaluating indicator:2）Device-associated composite endpoint (Do CE)(1 month)
- safety evaluating indicator:4）Incidence of device defects(1 month)
- Secondary effectiveness evaluating indicator:5)Instrument performance evaluation(1 month)
- Secondary effectiveness evaluating indicator:3）Rutherford grade(1 month, 6 months after surgery)
- safety evaluating indicator:1) Major Adverse Event (MAE)(1 month, 6 months after surgery)
- safety evaluating indicator:3）Adverse events / Serious adverse events (AE / SAE)(1 month, 6 months after surgery)
研究者
研究点 (1)
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