Peripheral Arterial DiseaseNCT05435716
Clinical Trial of C-Wave™ Peripheral Lithoclasty System Catheter System
A study testing C-wave™ peripheral seismic waveguide system and Peripheral vascular balloon dilatation catheter (PTA) in people with Peripheral Arterial Disease, run by Suzhou Zhonghui Medical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- C-wave™ peripheral seismic waveguide system and Peripheral vascular balloon dilatation catheter (PTA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2021to 8 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
C-waveTM peripheral seismic waveguide system
Shanghai, Shanghai Municipality
Sally Yan, 18800263183, sally.yan@hh-healthcare.com
About this study
Official title: 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 ).
- Conditions
- Peripheral Arterial Disease
- Being tested
- C-wave™ peripheral seismic waveguide system, Peripheral vascular balloon dilatation catheter (PTA)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-wave™ peripheral seismic waveguide systemDevice
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral seismic catheterization system (IVL) + drug-coated balloon (DCB) and/or stent | Experimental | Not described Receives: Device: C-wave™ peripheral seismic waveguide system |
| PTA + DRUG-coated balloon (DCB) and/or stent | Other | Not described Receives: Device: Peripheral vascular balloon dilatation catheter (PTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Peri-Procedural
Secondary outcomes (7)
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.
Measured: 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
Measured: 30 days
Clinical Success ABI
Defined as ankle-brachial index ABI reported as change from baseline
Measured: 30 days
Clinical Success Rutherford Category
Defined as Rutherford Category reported as change from baseline
Measured: 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
Measured: Peri-Procedural
Intraoperative complication
Measured: 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.
Measured: Peri-Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start5 Aug 2021
- Primary completion8 Sep 2023 (estimated)
- Study completion8 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zhonghui Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435716
- Sponsor's protocol ID
- YYS-2021-07-01
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Trial of C-wave™ Peripheral Lithoclasty Catheter System in Peripheral Arterial Angioplasty
- ClinicalTrials.gov ID
- NCT05435716
- Acronym / sponsor ID
- YYS-2021-07-01
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Suzhou Zhonghui Medical Technology Co., Ltd.University, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 8 Sep 2023 (estimated)
- Study completion
- 8 Sep 2023 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-wave™ peripheral seismic waveguide systemIn 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. | Device | Peripheral seismic catheterization system (IVL) + drug-coated balloon (DCB) and/or stent |
| Peripheral vascular balloon dilatation catheter (PTA)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. | Device | PTA + DRUG-coated balloon (DCB) and/or stent |
Primary outcome
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
7 secondary outcomes
Primary patency rate of target lesion
Time frame: Immediately after the procedure、 30 days
new-onset Major Adverse Events (MAEs)
Time frame: 30 days
Clinical Success ABI
Time frame: 30 days
Clinical Success Rutherford Category
Time frame: 30 days
Performance of Device
Time frame: Peri-Procedural
Intraoperative complication
Time frame: Peri-Procedural
Device defect (for test group only)
Time frame: Peri-Procedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-wave™ peripheral seismic waveguide system and Peripheral vascular balloon dilatation catheter (PTA) in people with Peripheral Arterial Disease, run by Suzhou Zhonghui Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Yan (18800263183, Sally.yan@hh-healthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success Rate, TSR (time frame: Peri-Procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.