DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: paclitaxel-coated balloon angioplasty or bare mental stents implantation.
- Who it may be relevant to
- Registry conditions: Safety Issues, Efficacy, Self. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device 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
Primary outcome measures
- 1-year primary patency rate [Time frame: 1 year]
Secondary outcome measures (1)
- clinical-driven target lesion revascularization [Time frame: 1, 2 and 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT05517291 · PASS