Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

NCT ID: NCT00673985

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2010-10-31

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.

Conditions

Intermittent Claudication; Atherosclerotic Disease; Arterial Occlusive Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

PTA Only: Active Comparator

Percutaneous transluminal angioplasty (PTA) alone

Group Type: ACTIVE_COMPARATOR

Percutaneous Transluminal Angioplasty

Intervention Type: OTHER

Balloon Angioplasty

2

Test Arm: Experimental

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.

Group Type: EXPERIMENTAL

LifeStent NT™ Self-Expanding Peripheral Stent

Intervention Type: DEVICE

Balloon angioplasty plus stent

Interventions

Percutaneous Transluminal Angioplasty

Balloon Angioplasty

Intervention Type: OTHER

LifeStent NT™ Self-Expanding Peripheral Stent

Balloon angioplasty plus stent

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry T Katzen, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Cardiac & Vascular Institute, Miami, FL

John R Laird, MD

Role: PRINCIPAL_INVESTIGATOR

Vascular Center at the University of California, Davis Medical Center

References

Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Cao AY, Jaff MR; RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012 Feb;19(1):1-9. doi: 10.1583/11-3627.1.

Reference Type: DERIVED

PMID: 22313193 (View on PubMed)

Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.

Reference Type: DERIVED

PMID: 20484101 (View on PubMed)

Other Identifiers

2003-12

Identifier Type: -

Identifier Source: org_study_id