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

Primary Purpose

Intermittent Claudication, Atherosclerotic Disease, Arterial Occlusive Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Percutaneous Transluminal Angioplasty

LifeStent NT™ Self-Expanding Peripheral Stent

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring SFA, Edwards, Popliteal, LifeStent, PTA, Nitinol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

PTA Only: Active Comparator Percutaneous transluminal angioplasty (PTA) alone

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.

Outcomes

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.

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

Full Information

NCT ID

NCT00673985

First Posted

February 14, 2008

Last Updated

July 12, 2017

Sponsor

C. R. Bard

Collaborators

CardioVascular Research Foundation, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00673985

Brief Title

Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

Acronym

RESILIENT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

C. R. Bard

Collaborators

CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intermittent Claudication, Atherosclerotic Disease, Arterial Occlusive Disease

Keywords

SFA, Edwards, Popliteal, LifeStent, PTA, Nitinol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

246 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

PTA Only: Active Comparator Percutaneous transluminal angioplasty (PTA) alone

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Percutaneous Transluminal Angioplasty

Intervention Description

Balloon Angioplasty

Intervention Type

Device

Intervention Name(s)

LifeStent NT™ Self-Expanding Peripheral Stent

Intervention Description

Balloon angioplasty plus stent

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

30 Day, 6 Month and12 Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barry T Katzen, MD

Organizational Affiliation

Baptist Cardiac & Vascular Institute, Miami, FL

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John R Laird, MD

Organizational Affiliation

Vascular Center at the University of California, Davis Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

22313193

Citation

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.

Results Reference

derived

PubMed Identifier

20484101

Citation

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.

Results Reference

derived

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Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

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