Actively Recruiting
Paclitaxel Coated Balloon Angioplasty Versus Primary Selective Stenting in the Treatment of TASC C/D Chronic Femoropopliteal Artery Occlusive Disease: A Multicenter Randomized Clinical Trial
Led by Peking Union Medical College Hospital · Updated on 2022-12-06
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the mid- and long-term results of two treatments for patients with TASC C/D chronic femoropopliteal artery occlusive disease. This condition involves blockages in the femoral and popliteal arteries. The study aims to compare the outcomes between using a paclitaxel-coated balloon and primary selective stenting. This is a multicenter randomized clinical trial sponsored by Peking Union Medical College Hospital. Participants in this trial are randomly assigned to one of two groups. One group receives paclitaxel-coated balloon angioplasty, which may include bailout stenting if needed. The other group undergoes primary selective stenting using bare metal stents. The treatments focus on arteries with lesions not exceeding 30 cm in length and specific vessel size criteria. The study does not use masking or blinding. During the trial, participants will be monitored for the primary outcome of the one-year primary patency rate, which assesses how well the treated artery remains open. Secondary outcomes include the need for clinical-driven target lesion revascularization at one, two, and three years. Follow-up visits and required tests will be conducted according to the study schedule. Participants must agree to attend these visits and complete the testing throughout the study period, which lasts up to several years to evaluate mid- and long-term effects.
CONDITIONS
Brief Title
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Signed informed consent approved by Medical Ethics Committee
- Willingness to attend follow-up visits and complete required testing
- Rutherford category 2 to 5
- Presence of de novo TASC C/D femoropopliteal artery lesions not extending beyond segment P1 of popliteal artery
- Target lesion length of 30 cm or less
- Reference vessel diameter greater than 4 mm and less than 6.5 mm by visual assessment
- Patent inflow artery with less than 30% stenosis and at least one infrapopliteal artery to the ankle with less than 50% diameter stenosis
- Successful guidewire traversal of the target treatment segment
You will not qualify if you...
- Acute thrombus in the target vessels
- Vessel stenosis or occlusion caused by Buerger's disease or autoimmune arteritis
- Prior stent implantation with in-stent restenosis or occlusion in the target vessel
- Reintervention of the target lesion less than 90 days before the study procedure
- Acquired thrombophilia or uncontrolled hypercoagulation states
- Life expectancy less than 12 months
- Severe renal impairment (serum creatinine 65 2.5 mg/dl) or dependence on hemodialysis
- Pregnancy, suspected pregnancy, or breastfeeding during the study period
- Contraindication to contrast media or any required study medications (antiplatelet, anticoagulant, thrombolytic agents, etc.)
- Hypersensitivity to nitinol and/or paclitaxel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants receive either paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare metal stents implantation as part of the treatment.
1 procedure visit (in-person)
Duration - Up to 3 years
Participants are monitored for clinical outcomes including primary patency and target lesion revascularization.
Follow-up visits at 1, 2, and 3 years
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
L
Leng Ni, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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