Clinical trial NCT05435716: Clinical Trial of C-Wave™ Peripheral Lithoclasty System Catheter System
Official title: Efficacy and Safety Trial of C-wave™ Peripheral Lithoclasty Catheter System in Peripheral Arterial Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Suzhou Zhonghui Medical Technology Co., Ltd.
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 ).


Eligibility criteria: 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.

Primary outcomes:
measure: Technical Success Rate, TSR
timeFrame: Peri-Procedural
Secondary outcomes:
measure: Primary patency rate of target lesion
timeFrame: Immediately after the procedure、 30 days
measure: new-onset Major Adverse Events (MAEs)
timeFrame: 30 days
measure: Clinical Success ABI
timeFrame: 30 days
measure: Clinical Success Rutherford Category
timeFrame: 30 days
measure: Performance of Device
timeFrame: Peri-Procedural
measure: Intraoperative complication
timeFrame: Peri-Procedural
measure: Device defect (for test group only)
timeFrame: Peri-Procedural
Other outcomes:
Locations:
city: Shanghai
country: China
facility: C-waveTM peripheral seismic waveguide system
state: Shanghai
Study officials:
References: