Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

NCT00673985 | Completed DMC

• 1 other identifier: 2003-12
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

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

Conditions

Intermittent Claudication; Atherosclerotic Disease; Arterial Occlusive Disease

Keywords

SFA, Edwards, Popliteal, LifeStent, PTA, Nitinol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Other: Percutaneous Transluminal Angioplasty

2

EXPERIMENTAL

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

Interventions

Percutaneous Transluminal Angioplasty OTHER

Balloon Angioplasty

1

LifeStent NT™ Self-Expanding Peripheral Stent DEVICE

Balloon angioplasty plus stent

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead
• CardioVascular Research Foundation, Korea: collaborator

Related Publications (2)

• 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.

  PMID: 22313193 DERIVED

• 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.

  PMID: 20484101 DERIVED

MeSH Terms

Conditions

Intermittent Claudication; Arterial Occlusive Diseases; Truncus Arteriosus, Persistent

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aortopulmonary Septal Defect; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: May 7, 2008
• Study Start: July 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: October 1, 2010
• Last Updated: July 14, 2017

Record last verified: 2017-07