NCT07839143尚未招募不适用
A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Trial Evaluating the Safety and Efficacy of Single-use Peripheral Intravascular Shock Wave Catheters Combined With Intravascular Shock Wave Therapy Devices for Peripheral Artery Calcified Lesions.
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.0 个研究点目标入组 158 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 主要终点
- Technical success rate
研究概览
简要总结
This trial is a prospective, multicenter, randomized, parallel controlled clinical trial. It to recruit patients with peripheral arterial calcified lesions, who will be randomly assigned in a 1:1 ratio to either the group or the control group. Subjects in the experimental group will use a disposable intra-peripheral vascularwave catheter combined with an intravascular shockwave therapy device to treat peripheral arterial calcified lesions and perform balloon dilation, while subjects in the control group will use a peripheral balloon dilation catheter to treat peripheral arterial calcified lesions and perform balloon dilation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General selection criteria
- •Age 18 to 80 years old, regardless of gender;
- •Rutherford grade is 2 to 5
- •As judged by the investigator, peripheral endovascular treatment is required;
- •The subject or their legal guardian has been informed of the purpose of the trial, consents to participate and signs the informed consent form;
- •The subject is willing comply with all assessment requirements in the trial;
- •Inclusion criteria for angiography:
- •1) Target lesions are vascular calcified lesions of grade Ⅲ to Ⅳ according to PARC classification: 2 Target lesions are located in native femoral artery and/or popliteal artery; 3) Total of target lesion ≤260mm; if it contains occlusive lesion, length of occlusive segment ≤100mm and total length of target lesion ≤20mm; 4) Target lesions have not undergone any surgical interventions including endovascular therapy and open surgery before, and the stenosis degree target lesion is ≥70% (visual assessment); 5) Reference vessel diameter of target is between 2.5mm and 8.0mm; 6) At least one distal outflow tract of target lesion is (vascular stenosis degree ≤50% by visual assessment), with blood flow reaching foot (not dependent on collateral circulation); or the patient has successfully undergone treatment for target lesion before (i.e., residual stenosis degree ≤30% by visual assessment after treatment, without serious complications); 7) The ipsilateral inflow tract of target lesion is patent (vascular stenosis degree ≤50% by visual assessment), or the patient has successfully undergone treatment for lesion before (i.e., residual stenosis degree ≤30% by visual assessment treatment, without serious complications);
排除标准
- •General Exclusion Criteria
- •History of amputation of target limb or planned major amputation (above the ankle
- •INR > 3 or platelet count < 60×10^9/L;
- •Patients with known renal insufficiency (ser creatinine >2.5 mg/dL or 220 μmol/L) or renal failure requiring long-term dialysis;
- •Patients with known contraindications to antiplatelet andagulant therapy;
- •Patients with known allergies to contrast agents used in endovascular therapy and experimental device materials;
- •Patients who have receivedbolytic therapy in the target vessel within 14 days prior to signing informed consent; ) Patients who have experienced myocardial infarction within 60 days prior to signing informed consent;
- •8) Patients who have experienced stroke within 60 days prior to signing informed consent; 9) Women of childbearing age who are pregnant, breastfeeding or planning pregnancy; 10) Patients participating in other medical device or drug clinical trials; 11) Other reasons considered by the investigator as inappropriate for participation in the trial.
- •Angiography exclusion criteria:
- •The target vessel has evidence of aneurysm or acute/chronic thrombosis;
- •The vessel is highly tortuous (the visual arc is greater than 30°);
- •The guidewire cannot pass through the target lesion; 4 There is in-stent restenosis in the target lesion area;
- •5) Before treating the lesion with research devices, ablative devices such as cutting balloons, scoring balloons, compliant balloons, mammillary balloons, pronged balloons, plaque excision devices, excimer laser systems, and peripheral throm aspiration catheters need to be used.
研究组 & 干预措施
experimental group
Experimental
The subjects in the experimental group used disposable peripheral intravascular shockwave catheters with intravascular shockwave therapy devices to treat peripheral artery calcification lesions and perform balloon dilatation.
干预措施: Interventional therapy in the experimental group (Procedure)
control group
Experimental
The subjects in the control group used peripheral balloon dilatation catheters to treat artery calcified lesions and conduct balloon dilatation.
干预措施: Interventional therapy in the control group (Procedure)
结局指标
主要结局
Technical success rate
时间窗: immediately after surgery
After treatment with the investigational device, residual diameter stenosis of the target lesion is ≤0% and no dissection of grade ≥D is present.
次要结局
- Device success rate(immediately after surgery)
- Primary patency rate of target lesions at 30 days after operation(30 days after operation)
- Changes in ankle-brachial index at 7 days postoperatively or on the day discharge, and at 30 days postoperatively.(7 days post-operation or the day of discharge, 30 days post-operation)
- Changes in Rutherford grade at 7 days postoperatively or discharge day, 3 days postoperatively, and 6 months postoperatively(7 days after surgery or discharge date, 30 days after surgery, 6 months surgery)
- Incidence rate of clinically driven target lesion revascularization (CD-TLR) at30 days and 6 months after surgery(30 days after surgery, 6 months after surgery)
研究者
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