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

NCT05435716 | Unknown

• 1 other identifier: YYS-2021-07-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 ).

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Primary patency rate of target lesion

  Immediately after the procedure、 30 days

• new-onset Major Adverse Events (MAEs)

  30 days

• Clinical Success ABI

  30 days

• Clinical Success Rutherford Category

  30 days

• Performance of Device

  Peri-Procedural

Study Arms (2)

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

EXPERIMENTAL

Device: C-wave™ peripheral seismic waveguide system

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

OTHER

Device: Peripheral vascular balloon dilatation catheter (PTA)

Interventions

C-wave™ peripheral seismic waveguide system DEVICE

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.

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

Peripheral vascular balloon dilatation catheter (PTA) DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Suzhou Zhonghui Medical Technology Co., Ltd.: lead

Study Sites (1)

C-waveTM peripheral seismic waveguide system

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Sally Yan

CONTACT

18800263183; Sally.yan@hh-healthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 28, 2022
• Study Start: August 5, 2021
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: September 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)