RecruitingNot ApplicableNCT05517291

DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease

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

Sponsor

Peking Union Medical College Hospital

Enrollment

200 participants

Start Date

Sep 18, 2022

Study Type

INTERVENTIONAL

Conditions

Efficacy, Self Safety Issues

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria9

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 2-5.
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 Criteria10

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.

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Interventions

DEVICEpaclitaxel-coated balloon angioplasty or bare mental stents implantation

paticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly