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BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease

A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)

NCT02228564•C. R. Bard

View on ClinicalTrials.gov

Summary

Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject provides written informed consent using an Informed Consent Form approved by the Ethics Committee/ Institutional Review Board for the site.
•Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
•Subject is a male or non-pregnant female ≥ 21 years old with an expected lifespan sufficient to allow for completion of all study procedures.
•Subject has intermittent claudication (Rutherford Category 2-3) or ischemic rest pain (Rutherford Category 4).
•Subject is able and willing to comply with any required medication regimen.
•Subject has evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion in the native common and/or external iliac artery that is ≥ 50% stenosed (including total occlusions).
•The target lesion can be successfully crossed with a guide wire and pre-dilated with an appropriately sized PTA balloon.
•The reference vessel diameter is between 4.5 mm -12.0 mm in diameter.
•The target lesion is ≤ 100 mm in combined length (per side).
•The subject has angiographic evidence of a patent (\< 50% stenosis) profunda and/or superficial femoral artery (SFA) in the target limb.

Exclusion Criteria

•The subject is unable or unwilling to provide written informed consent or to conform to the study protocol follow-up procedures and visits.
•The subject is or plans to become pregnant during the study.
•The subject is asymptomatic, has mild claudication or critical limb ischemia with tissue loss described as Rutherford Category 0, 1, 5 or 6.
•The subject has a vascular graft previously implanted in the native iliac vessel.
•The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA) within 3 months prior to the index procedure.
•The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
•The subject has a serum creatinine ≥ 2.5 mg/dl or is on dialysis.
•The subject has a known allergy or sensitivity to stainless steel (i.e., Nickel), ePTFE, or has intolerance to the antiplatelet, anticoagulant or thrombolytic medications required per the protocol.
•The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
•The subject had a prior vascular intervention within 30 days before or planned for within 30 days after the index procedure.
+11 more criteria

Locations (20)

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Vascular and Interventional Specialists of Orange County

Orange, California, United States

UC Davis Cardiovascular Medicine

Sacramento, California, United States

Florida Research Network

Gainesville, Florida, United States

Baptist Medical Center

Jacksonville, Florida, United States

Lakeland Regional Medical Center

Lakeland, Florida, United States

Mount Sinai Medical Center

Miami, Florida, United States

University of Massachusetts Worcester

Worcester, Massachusetts, United States

Kansas City Vascular Foundation

Kansas City, Missouri, United States

CaroMont Regional Medical Center

Gastonia, North Carolina, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2018

Last Updated

October 8, 2020

Enrollment

155

ACTUAL participants

Conditions

Peripheral Artery DiseasePeripheral Vascular DiseaseArterial Occlusive Disease

Interventions

Percutaneous transluminal angioplasty (PTA)

PROCEDURE

LIFESTREAM™ covered stent

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease

Inclusion Criteria

Exclusion Criteria

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease

VITUS Post-Market Registry

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Vascular Lab Resource (VLR) Biorepository