Clinical Trial of C-Wave™ Peripheral Lithoclasty System Catheter System

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of peripheral shock catheter system in peripheral arterial angioplasty.This trial is a prospective, multicenter, open, randomized, parallel controlled and superior clinical trial. Select ≥3 hospitals with the qualification of national clinical trial institutions as clinical trial centers, and plan to enroll a total of 120 subjects. The ratio of subjects in the trial group and the control group is 1: 1 (60 in the trial group and 60 in the control group). This study mainly includes four stages: the screening (baseline) period (-14  0 days), the operation day (the day of treatment), the postoperative visit (0 7days ) and the 30-day follow-up (30 ±7days ).

Official Title
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Efficacy and Safety Trial of C-wave™ Peripheral Lithoclasty Catheter System in Peripheral Arterial Angioplasty

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: C-wave™ peripheral seismic waveguide system
* Device: Peripheral vascular balloon dilatation catheter (PTA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of subject is greater than or equal to 18. Rutherford Grade 2 5; The resting ABI of target limb ≤0.90, or ≤0.75 after exercise; Agree to participate in this study and sign informed consent; Estimated life expectancy >1 year. According to the diagnosis of medical institutions or participating researchers, peripheral arterial tubuloplasty (including peripheral seismic catheterization system or peripheral vascular balloon dilatation catheter for lumen preparation, and subsequent drug-coated balloon therapy or stent implantation; Angiographic Inclusion Criteria Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery). The target vessel has not received any prior surgical intervention (within 3 months), including endovascular therapy and open surgery, and the stenosis rate ≥ 50% or occlusive lesions were assessed preoperatively; The target vessels were 2-7.5 mm in diameter and had at least one normal subgenicular outflow artery (stenosis rate ≤50%). If the stenosis rate of the target lesion is 50-99% and the lesion length is less than or equal to 260mm, the target lesion may be continuous or intermittent, or both. If the target lesions were chronic occlusive lesions, the length of occlusive lesions was ≤100mm, and the total length of lesions was ≤260mm; The calcification degree is at least moderate, which is defined as the presence of calcification signs in the vessels of the target lesions under CTA or fluoroscopy, and the calcification conditions are 1) located on both sides of the target lesions, 2) if the length of the target lesions is less than 50mm, the length of the calcification lesions is at least 20mm; If the target lesion length ≥50mm and < 100mm, the calcification lesion length should be at least 50% of the target lesion. If the target lesion length is ≥100mm, the calcification lesion length should be greater than 50mm. If there are signs of acute or chronic thrombus in the target blood vessels, the above conditions are met after routine clinical treatment. Note: Patients with inflow tract and outflow tract that are qualified for inclusion in this study after routine clinical treatment can be included. cc Exclusion Criteria: The Rutherford rating is 0, 1 and 6; Severe infection of target limb requiring antibiotics or planned amputation above the ankle; Previous intra-arterial therapy or open surgery had been performed on the target limb (within 1 month); Coagulation abnormalities are known to exist; Coagulation abnormalities are known to exist; A history of stroke or myocardial infarction within 60 days; Subjects who have participated in clinical trials of other medical devices or drugs during the same period; Women who are pregnant or breastfeeding; Other conditions that the investigator considers inappropriate for clinical trial participation; Angiographic Exclusion criteria in-stent restenosis A highly tortuous artery; The inflow vessels upstream of the target lesion area have other obvious vascular lesions that have not been successfully treated (stenosis rate > 50%); There is an aneurysm in the target vessel.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral seismic catheterization system (IVL) + drug-coated balloon (DCB) and/or stent<br> | Device: C-wave™ peripheral seismic waveguide system<br>* In the experimental group, if the target lesions did not show flow-limiting dissection or severe elastic retraction, drug-coated balloon was subsequently performed after lumen preparation by peripheral seismic catheterization system (IVL). If there is limited flow dissection or severe elastic retraction, stent therapy is followed.<br>|
| Other: PTA + DRUG-coated balloon (DCB) and/or stent<br> | Device: Peripheral vascular balloon dilatation catheter (PTA)<br>* Subjects in the control group received balloon dilatation catheter in peripheral blood for lumen preparation, and if the target lesions did not show flow-limiting interlayer or severe elastic retraction, drug-coated balloon therapy was subsequently performed. If there is limited flow dissection or severe elastic retraction, stent therapy is followed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success Rate, TSR | Procedural success rate is defined as the ratio of participants whose residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting | Peri-Procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate of target lesion | as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram or CTA greater than or equal to 50% stenosis. | Immediately after the procedure、 30 days | 
| new-onset Major Adverse Events (MAEs) | Need for emergency surgical revascularization of target limb Unplanned target limb major amputation (above the ankle) Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization Perforations that require an intervention, including bail-out stenting | 30 days | 
| Clinical Success ABI | Defined as ankle-brachial index ABI reported as change from baseline | 30 days | 
| Clinical Success Rutherford Category | Defined as Rutherford Category reported as change from baseline | 30 days | 
| Performance of Device | Performance of Device is composed of as Guidewire compatibility；Introducer sheath compatibility；visibility of the catheter 、emitter and marker；catheter connection；corssing ability of thecatheter | Peri-Procedural | 
| Intraoperative complication |  | Peri-Procedural | 
| Device defect (for test group only) | Device defects refer to unreasonable risks that may endanger human health and life safety, such as label errors, quality problems, failures. | Peri-Procedural |