peripheral arteria disease
Conditions
Interventions
Experimental group:Balloon Expandable Vascular Covered Stent Therapy
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. The subject provides inform consent using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) / Institutional Review Board (IRB) for the site. 2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits. 3. The subject is a male or non-pregnant female >= 18 years old with an expected lifespan sufficient to allow for completion of all study procedures. Female subjects of childbearing potential must have a negative pregnancy test (urine or blood) within 14 days prior to the index procedure. 4. The subject has intermittent claudication, ischemic rest pain or ulceration. 5. The subject is able and willing to comply with any required medication regimen. 6. The subject has evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion (s) in the native common and/or external iliac artery that is (are) >= 50% stenosed (including total occlusions) as determined by the Investigators visual estimate.
Exclusion criteria
Exclusion criteria: 1. The subject has a vascular graft previously implanted in the native iliac vessel. 2. The subject suffered a stroke or transient ischemic attack (TIA) within 3 months prior to the index procedure. 3. The subject has a known uncorrectable bleeding diathesis or active coagulopathy (platelet count = 2.5 mg/dl or is currently on dialysis. 5. The subject has a known allergy or sensitivity to stainless steel (i.e., Nickel), ePTFE, or has intolerance to the antiplatelet, anticoagulant or thrombolytic medications required per the protocol. 6. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device and/or procedure-related death or MI through 30 days post-index procedure.;Any TLR, target limb(s) major amputation, or restenosis through 9-months post-index procedure.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute Procedure Success (lesion success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb(s), and thrombosis of target vessel) prior to hospital discharge)).;Acute Lesion Success (Attainment of < 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation)).;Acute Technical Success (successful deployment of the BARD LIFESTREAM Balloon Expandable Vascular Covered Stent at the intended location).;Target Lesion Revascularization (TLR) at 9- and 12-months post-index procedure.;Target Vessel Revascularization (TVR) at 9- and 12-months post-index procedure.;Primary Patency at 9- and 12-months post-index procedure.;Primary Assisted Patency at 9- and 12-months post-index procedure.;Secondary Patency at 9- and 12-months post-index procedure.;Walking Impairment Questionnaire at baseline,30-days and 6-, 9-, and 12-months post-index procedure.; | — |
Countries
China
Contacts
Public ContactYuan Ding
West China Hospital, Sichuan University
Outcome results
None listed