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Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study (RESILIENT)

This study has been completed.
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00673985
First received: February 14, 2008
Last updated: October 21, 2010
Last verified: October 2010
History of Changes
  Purpose

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


Condition Intervention
Intermittent Claudication
Atherosclerotic Disease
Arterial Occlusive Disease
 Other: Percutaneous Transluminal Angioplasty
Device: LifeStent NT™ Self-Expanding Peripheral Stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • 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. [ Time Frame: 30 Day, 6 Month, and 12 Month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 30 Day, 6 Month and12 Month ] [ Designated as safety issue: Yes ]

Enrollment: 246
Study Start Date: July 2004
Study Completion Date: October 2010
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

PTA Only: Active Comparator

Percutaneous transluminal angioplasty (PTA) alone

 Other: Percutaneous Transluminal Angioplasty
Balloon Angioplasty
Experimental: 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.

 Device: LifeStent NT™ Self-Expanding Peripheral Stent
Balloon angioplasty plus stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673985

Sponsors and Collaborators
C. R. Bard
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Barry T Katzen, MD Baptist Cardiac & Vascular Institute, Miami, FL
Principal Investigator: John R Laird, MD Vascular Center at the University of California, Davis Medical Center
  More Information

No publications provided by C. R. Bard

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: John Reviere, C. R. Bard
ClinicalTrials.gov Identifier: NCT00673985     History of Changes
Other Study ID Numbers: 2003-12
Study First Received: February 14, 2008
Last Updated: October 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
SFA, Edwards, Popliteal, LifeStent, PTA, Nitinol

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Intermittent Claudication
Peripheral Vascular Diseases
Peripheral Arterial Disease
Vascular Diseases
 Cardiovascular Diseases
Arteriosclerosis
Signs and Symptoms
Atherosclerosis

ClinicalTrials.gov processed this record on May 19, 2013