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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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.
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.
C-waveTM peripheral seismic waveguide system
Shanghai, Shanghai Municipality, China
RECRUITINGTechnical 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
Time frame: Peri-Procedural
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.
Time frame: 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
Time frame: 30 days
Clinical Success ABI
Defined as ankle-brachial index ABI reported as change from baseline
Time frame: 30 days
Clinical Success Rutherford Category
Defined as Rutherford Category reported as change from baseline
Time frame: 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
Time frame: Peri-Procedural
Intraoperative complication
Time frame: 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.
Time frame: Peri-Procedural
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