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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
The 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.
The 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.
Time frame: immediately after surgery
Device success rate
The interventional device successfully reached the lesion site, achieved successful expansion without any rupture, was successfully withdrawn.
Time frame: immediately after surgery
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
Time frame: 30 days after operation
Changes in ankle-brachial index at 7 days postoperatively or on the day discharge, and at 30 days postoperatively.
Time frame: 7 days post-operation or the day of discharge, 30 days post-operation
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
Time frame: 7 days after surgery or discharge date, 30 days after surgery, 6 months surgery
Incidence rate of clinically driven target lesion revascularization (CD-TLR) at30 days and 6 months after surgery
Incidence rate of clinically driven target lesion revascularization (CD-TLR) at30 days and 6 months after surgery
Time frame: 30 days after surgery, 6 months after surgery
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