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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Safety Issues; Efficacy, Self

Treatments: Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05517291

PASS

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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 2-5.
• 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

DCB

Experimental group

Description:

participants in this group will be received drug-coated balloon angioplasty

Treatment:

Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation

stenting

Active Comparator group

Description:

participants in this group will be received primary selective stenting

Treatment:

Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation