Paclitaxel Coated Balloon Angioplasty Versus Primary Selective Stenting in the Treatment of TASC C/D Chronic Femoropopliteal Artery Occlusive Disease: A Multicenter Randomized Clinical Trial

Peking Union Medical College Hospital1 site in 1 country200 target enrollmentSeptember 18, 2022

ConditionsSafety Issues Efficacy, Self

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Safety Issues
Sponsor: Peking Union Medical College Hospital
Enrollment: 200
Locations: 1
Primary Endpoint: 1-year primary patency rate
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.

Registry

clinicaltrials.gov

Start Date

September 18, 2022

End Date

December 31, 2027

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject age 18-85yrs.
•Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
•Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
•Rutherford category 2-
•Subject has a de novo TASC C/D femoropopliteal artery lesions which does not exceed to the segment P1 of popliteal artery.
•The total length of target lesion ≤30cm.
•Reference vessel diameter \>4 mm and \<6.5 mm by visual assessment.
•Patent inflow artery with stenosis \<30% and at least 1 infrapopliteal artery to the ankle (\<50% diameter stenosis).
•A guidewire has successfully traversed the target treatment segment.

Exclusion Criteria

•Acute thrombus in the target vessels.
•Vessel stenosis or occlusion due to Buerger's disease or autoimmune arteritis.
•Subject received prior stents implantation with in-stent restenosis or occlusion.
•Reintervention of the target lesion \<90 days before the study procedure.
•Acquired thrombophilia or uncontrolled hypercoagulation states.
•Life expectancy \<12 months.
•Severe renal（SCr≥2.5 mg/dl）or hemodialysis dependence.
•Pregnancy, suspected pregnancy, or breastfeeding during study period.
•Contraindication to contrast media or any study-required medication (antiplatelet, anticoagulant, or thrombolytic agents, etc.).
•Hypersensitivity to nitinol and/or paclitaxel.