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)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
China
Recruiting
More Peking Union Medical College Hospital trials in China
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.
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