Actively Recruiting
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
Led by Peking Union Medical College Hospital · Updated on 2022-12-06
200
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Informed consent signed and understanding of study participation
- Agreement to attend follow-up visits and complete tests
- Rutherford category 2 to 5
- Presence of de novo TASC C/D femoropopliteal artery lesions not extending beyond segment P1 of the popliteal artery
- Total lesion length 30 cm or less
- Reference vessel diameter greater than 4 mm and less than 6.5 mm
- 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 target vessels
- Vessel stenosis or occlusion caused by Buerger's disease or autoimmune arteritis
- Prior stent implantation with in-stent restenosis or occlusion
- Reintervention of target lesion within 90 days before study procedure
- Acquired thrombophilia or uncontrolled hypercoagulation
- Life expectancy less than 12 months
- Severe renal impairment (serum creatinine ≥2.5 mg/dl) or dependence on hemodialysis
- Pregnancy, suspected pregnancy, or breastfeeding during study
- Contraindications to contrast media or study-required medications (antiplatelet, anticoagulant, thrombolytic agents)
- Hypersensitivity to nitinol or paclitaxel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
L
Leng Ni, MD
CONTACT
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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