A Prospective, Multicenter, Randomized Controlled Trail Using Spot Stenting to Treat Lower Extremity Post-angioplasty Dissection

Zhejiang Zylox Medical Device Co., Ltd.12 sites in 1 country224 target enrollmentNovember 2022

Overview

This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.

Registry

clinicaltrials.gov

Start Date

November 2022

End Date

February 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

Responsible Party

Sponsor

•Age 18 to 80 years,male or female
•Lower extremity atherosclerotic occlusive disease
•After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F)
•Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent

•The target lesion has been stented or previously treated with bypass surgery
•Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
•Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
•More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb
•The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
•Planned amputation on the target limb
•Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol
•Uncontrollable infections
•Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial
•Participating in clinical trials of any other drug or medical device and not yet out of the study

primary patency rate at 12 months after operation

Time Frame: 12 months

the rate of target limb major amputation(30 days, 6 months,12 months)
the rate of device defect(Intraoperation, 12 months)
success rate of the device(Intraoperation)
success rate of the technique(post operation)
rate of CD-TLR(6 months,12 months)
ABI(post operation, 6 months,12 months)
Rutherford classification(post operation, 6 months,12 months)
the incidence of major adverse events(30 days, 6 months,12 months)
the incidence of SAE(Intraoperation, post operation, 30 days, 6 months,12 months)
the incidence of adverse events(Intraoperation, post operation, 30 days, 6 months,12 months)