Efficacy, Self, Safety Issues
Conditions
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.
Interventions
DEVICEpaclitaxel-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
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year primary patency rate | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| clinical-driven target lesion revascularization | 1, 2 and 3 years |
Countries
China
Contacts
Primary ContactLeng Ni, MD
Outcome results
None listed