- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05435716
Clinical Trial of C-Wave™ Peripheral Lithoclasty System Catheter System
September 20, 2022 updated by: Suzhou Zhonghui Medical Technology Co., Ltd.
Efficacy and Safety Trial of C-wave™ Peripheral Lithoclasty Catheter System in Peripheral Arterial Angioplasty
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 ).
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sally Yan
- Phone Number: 18800263183
- Email: sally.yan@hh-healthcare.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- C-waveTM peripheral seismic waveguide system
-
Contact:
- Sally Yan
- Phone Number: 18800263183
- Email: sally.yan@hh-healthcare.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional 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
|
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.
|
Other: PTA + DRUG-coated balloon (DCB) and/or stent
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical Success Rate, TSR
Time Frame: Peri-Procedural
|
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
Time Frame: Immediately after the procedure、 30 days
|
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
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new-onset Major Adverse Events (MAEs)
Time Frame: 30 days
|
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
Time Frame: 30 days
|
Defined as ankle-brachial index ABI reported as change from baseline
|
30 days
|
Clinical Success Rutherford Category
Time Frame: 30 days
|
Defined as Rutherford Category reported as change from baseline
|
30 days
|
Performance of Device
Time Frame: Peri-Procedural
|
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
Time Frame: Peri-Procedural
|
Peri-Procedural
|
|
Device defect (for test group only)
Time Frame: Peri-Procedural
|
Device defects refer to unreasonable risks that may endanger human health and life safety, such as label errors, quality problems, failures.
|
Peri-Procedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2021
Primary Completion (Anticipated)
September 8, 2023
Study Completion (Anticipated)
September 8, 2023
Study Registration Dates
First Submitted
June 15, 2022
First Submitted That Met QC Criteria
June 23, 2022
First Posted (Actual)
June 28, 2022
Study Record Updates
Last Update Posted (Actual)
September 22, 2022
Last Update Submitted That Met QC Criteria
September 20, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YYS-2021-07-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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