Ireland
--:--IST
Recruiting Not applicable

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

NCT05517291 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2022-09-18
Last updated
2022-12-06

Condition(s) studied

Safety IssuesEfficacy, Self

Investigational drug(s) / intervention(s)

paclitaxel-coated balloon angioplasty or bare mental stents implantation

paclitaxel-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

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 1-year primary patency rate — 1 year

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05517291 on ClinicalTrials.gov ↗ ← All trials in China