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

Not Applicable

Recruiting

• Conditions: Safety Issues; Efficacy, Self
• Interventions: Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation

• Registration Number: NCT05517291
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-09-18
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-04
• Last Update Posted: 2022-12-06
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stenting	paclitaxel-coated balloon angioplasty or bare mental stents implantation	participants in this group will be received primary selective stenting
DCB	paclitaxel-coated balloon angioplasty or bare mental stents implantation	participants in this group will be received drug-coated balloon angioplasty

Primary Outcome Measures

Name	Time	Method
1-year primary patency rate	1 year

Secondary Outcome Measures

Name	Time	Method
clinical-driven target lesion revascularization	1, 2 and 3 years

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China