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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 ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral seismic catheterization system (IVL) + drug-coated balloon (DCB) and/or stent | Experimental |
| |
| PTA + DRUG-coated balloon (DCB) and/or stent | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the procedure、 30 days |
| new-onset Major Adverse Events (MAEs) |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sally Yan | Contact | 18800263183 | Sally.yan@hh-healthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C-waveTM peripheral seismic waveguide system | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
| 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. |
|
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 | Defined as ankle-brachial index ABI reported as change from baseline | 30 days |
| Clinical Success Rutherford Category | Defined as Rutherford Category reported as change from baseline | 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 | Peri-Procedural |
| Intraoperative complication | 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. | Peri-Procedural |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |