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

July 12, 2017 updated by: C. R. Bard

A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 30 Day, 6 Month, and 12 Month
30 Day, 6 Month, and 12 Month

Secondary Outcome Measures

Outcome 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
Time Frame: 30 Day, 6 Month and12 Month
30 Day, 6 Month and12 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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