DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease

Study Overview
=================
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.

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

Conditions
-----------------
Safety Issues, Efficacy, Self

Intervention / Treatment
-----------------
* Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB<br>participants in this group will be received drug-coated balloon angioplasty | Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation<br>* paticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly<br>|
| Active Comparator: stenting<br>participants in this group will be received primary selective stenting | Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation<br>* paticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year primary patency rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical-driven target lesion revascularization |  | 1, 2 and 3 years |