This trial is a prospective, multicenter, randomized, parallel controlled clinical trial. It to recruit patients with peripheral arterial calcified lesions, who will be randomly assigned in a 1:1 ratio to either the group or the control group. Subjects in the experimental group will use a disposable intra-peripheral vascularwave catheter combined with an intravascular shockwave therapy device to treat peripheral arterial calcified lesions and perform balloon dilation, while subjects in the control group will use a peripheral balloon dilation catheter to treat peripheral arterial calcified lesions and perform balloon dilation.
Age 18 to 80 years old, regardless of gender;
Rutherford grade is 2 to 5
As judged by the investigator, peripheral endovascular treatment is required;
The subject or their legal guardian has been informed of the purpose of the trial, consents to participate and signs the informed consent form;
History of amputation of target limb or planned major amputation (above the ankle
INR > 3 or platelet count < 60×10^9/L;
Patients with known renal insufficiency (ser creatinine >2.5 mg/dL or 220 μmol/L) or renal failure requiring long-term dialysis;
Patients with known contraindications to antiplatelet andagulant therapy;
Parallel
Interventional therapy in the experimental group
Procedure/SurgeryThe subjects in the experimental group used disposable peripheral intravascular shockwave catheters combined with intravascular shockwave therapy devices to treat peripheral artery calcification lesions and perform balloon dilatation.
Interventional therapy in the control group
Procedure/SurgeryThe subjects in the control group used peripheral balloon dilatation catheters to treat peripheral artery calcified lesions and conduct balloon dilatation.
Technical success rate
After treatment with the investigational device, residual diameter stenosis of the target lesion is ≤0% and no dissection of grade ≥D is present.
Device success rate
The interventional device successfully reached the lesion site, achieved successful expansion without any rupture, was successfully withdrawn.
Primary patency rate of target lesions at 30 days after operation
No clinically driven target lesion revascularization (CD-TLR) and no target lesionosis detected by imaging examinations
Changes in ankle-brachial index at 7 days postoperatively or on the day discharge, and at 30 days postoperatively.
Changes in Rutherford grade at 7 days postoperatively or discharge day, 3 days postoperatively, and 6 months postoperatively
Changes in Rutherford grade at 7 days postoperatively or discharge day, 3 days postoperatively, and 6 months postoperatively
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This trial is not recruiting at the moment. You can still explore other options:
