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

NCT05517291 | Recruiting

• 1 other identifier: PASS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety Issues; Efficacy, Self

Outcome Measures

Primary Outcomes (1)

• 1-year primary patency rate

  1 year

Secondary Outcomes (1)

• clinical-driven target lesion revascularization

  1, 2 and 3 years

Study Arms (2)

DCB

EXPERIMENTAL

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

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

stenting

ACTIVE COMPARATOR

participants in this group will be received primary selective stenting

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

Interventions

paclitaxel-coated balloon angioplasty or bare mental stents implantation DEVICE

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

DCB; stenting

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Central Study Contacts

Leng Ni, MD

CONTACT

86-1069152501; nileng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: September 18, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

CN (1)