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

Suzhou Zhonghui Medical Technology

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: Peripheral vascular balloon dilatation catheter (PTA); Device: C-wave™ peripheral seismic waveguide system

Study type: Interventional

Funder types: Other

Identifiers

NCT05435716

YYS-2021-07-01

Details and patient eligibility

About

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 ).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age of subject is greater than or equal to 18.
2. Rutherford Grade 2~5;
3. The resting ABI of target limb ≤0.90, or ≤0.75 after exercise;
4. Agree to participate in this study and sign informed consent;
5. Estimated life expectancy >1 year.
6. 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
7. 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).
8. 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;
9. The target vessels were 2-7.5 mm in diameter and had at least one normal subgenicular outflow artery (stenosis rate ≤50%).
10. 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;
11. 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.
12. 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

1. The Rutherford rating is 0, 1 and 6;
2. Severe infection of target limb requiring antibiotics or planned amputation above the ankle;
3. Previous intra-arterial therapy or open surgery had been performed on the target limb (within 1 month);
4. Coagulation abnormalities are known to exist;
5. Coagulation abnormalities are known to exist;
6. A history of stroke or myocardial infarction within 60 days;
7. Subjects who have participated in clinical trials of other medical devices or drugs during the same period;
8. Women who are pregnant or breastfeeding;
9. Other conditions that the investigator considers inappropriate for clinical trial participation; Angiographic Exclusion criteria
10. in-stent restenosis
11. A highly tortuous artery;
12. The inflow vessels upstream of the target lesion area have other obvious vascular lesions that have not been successfully treated (stenosis rate > 50%);
13. There is an aneurysm in the target vessel.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

Peripheral seismic catheterization system (IVL) + drug-coated balloon (DCB) and/or stent

Experimental group

Treatment:

Device: C-wave™ peripheral seismic waveguide system

PTA + DRUG-coated balloon (DCB) and/or stent

Other group

Treatment:

Device: Peripheral vascular balloon dilatation catheter (PTA)