peripheral arteria disease
Conditions
Interventions
Control group:Drug-Eluting Bare Metal Stents
Experimental group:Heparin-Bonded Covered Stents
Sponsors
Department of Vascular Surgery, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Male or non-pregnant female subjects aged 18 years or older, with a life expectancy sufficient to complete all study procedures; (2) Diagnosis of femoropopliteal peripheral artery disease using preoperative CTA (Rutherford classification from 2 to 6); (3) Preoperative CTA indicating more than 70% stenosis in the femoropopliteal artery, with no limitation on lesion length; (4) Presence of at least one inflow artery or successfully treated inflow artery (iliac artery) and at least one outflow artery or successfully treated outflow below the knee; (5) Informed consent approved by the ethics committee.
Exclusion criteria
Exclusion criteria: (1) History of previous stent placement in the femoropopliteal artery (previous intervention by solely balloon angioplasty or arterial embolectomy are not excluded); (2) Known allergy to contrast agent; (3) History of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks prior to enrollment; (4) Stroke or TIA within 3 months prior to surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency;Maximum walking distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary patency;Freedom from target lesion revascularization;Freedom from major extremity amputation of index limb;Major adverse limb event ; | — |
Countries
China
Contacts
Public ContactDing Yuan
West China Hospital, Sichuan University
Outcome results
None listed