NCT05517291 DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
| NCT ID | NCT05517291 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Safety Issues |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-09-18 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-09-18 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05517291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Safety Issues. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05517291 currently recruiting?
Yes, NCT05517291 is actively recruiting participants. Contact the research team at nileng@163.com for enrollment information.
Where is the NCT05517291 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05517291 clinical trial?
NCT05517291 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 200 participants.