Arterial Occlusive Disease, Atherosclerotic Disease, Intermittent Claudication
Conditions
Keywords
SFA, Edwards, Popliteal, LifeStent, PTA, Nitinol
Brief summary
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone
Detailed description
The RESILIENT Trial is a dual stage clinical investigation designed to evaluate the safety and effectiveness of the Edwards Lifesciences self-expanding stent system. Phase 1 consists of a prospective, multi-center, non-randomized study with a peri-procedure endpoint. Phase 2 consists of a prospective, multi-center, randomized study with a 30-day primary safety endpoint and a 6-month primary effectiveness endpoint.
Interventions
Balloon Angioplasty
DEVICELifeStent NT™ Self-Expanding Peripheral Stent
Balloon angioplasty plus stent
Sponsors
CardioVascular Research Foundation, Korea
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent approved by the IRB. * ≥ 18 years old. * Lifestyle-limiting claudication defined as: Rutherford Cat. 1-3. * Target lesion(s) is de-novo or restenotic and located within the native SFA and/or proximal popliteal artery * Angiographic evidence of ≥ 50% stenosis or occlusion * Target RVD is ≥ 4.0 mm and ≤ 7.0 mm * Target total length of the lesion or series of lesions is ≤ 150 mm. * Angiographic evidence of at least one vessel runoff to the foot.
Exclusion criteria
* Unable to conform to the study protocol procedures and visits. * Lifestyle-limiting claudication/CLI (Rutherford Cat. 4-6) * Patients who are pregnant or planning to become pregnant during the clinical investigation * Contraindication to study related medications, Ni, Ti, Ta, or other media that is not amenable to pretreatment. * History of bleeding diatheses or coagulopathy. * Concomitant renal failure with a creatinine of \> 2.0 mg/dL. * Concomitant hepatic insufficiency, thrombophlebitis, uremia, SLE, or DVT at the time of the study procedure. * Receiving dialysis or immunosuppressive therapy. * Suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure. * Prior peripheral vascular bypass surgery involving the target limb. * Target vessel has been previously stented. * Target lesion(s) received angioplasty intervention ≤ 6 mo. prior * Any non-iliac percutaneous intervention(s) \< 7 days prior. * Currently participating in an investigational drug/device study. * Limited life expectancy of less than two years. * Extensive PVD that precludes safe insertion of an sheath. * Target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s). * Unresolved thrombus within the target vessel. * Poor inflow which would not support a vascular bypass graft. * Diagnosed with septicemia at the time of the study procedure. * Additional percutaneous interventional procedures (cardiac/peripheral) planned ≤ 30 days following procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. | 30 Day, 6 Month, and 12 Month |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel at 30-days post-procedure. Freedom from 30-day death and 6-month | 30 Day, 6 Month and12 Month |
Outcome results
None listed