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

NCT ID: NCT02228564

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-12-31

Brief 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.

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease; Arterial Occlusive Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LIFESTREAM™

This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.

Group Type: EXPERIMENTAL

Percutaneous transluminal angioplasty (PTA)

Intervention Type: PROCEDURE

Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

LIFESTREAM™ covered stent

Intervention Type: DEVICE

Implantation of the LIFESTREAM™ covered stent

Interventions

Percutaneous transluminal angioplasty (PTA)

Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Intervention Type: PROCEDURE

LIFESTREAM™ covered stent

Implantation of the LIFESTREAM™ covered stent

Intervention Type: DEVICE

Eligibility Criteria

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.
• The subject has another medical condition, which may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
• The subject is currently participating in an investigational drug, biologic, or another device study.

• The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath. The ipsilateral common femoral artery should be patent (< 50% stenosis).
• The target lesion requires treatment other than angioplasty to facilitate subject device delivery.
• The subject has severe calcification of the target lesion, preventing inflation of PTA balloon.
• The target lesion has been previously treated with a stent (bare or covered).
• The subject has angiographic evidence of acute thrombus at the target lesion.
• The target lesion involves the origin of the internal iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude the side branch.
• The target lesion located in the distal external iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude side branches or be exposed to compressive forces associated with the close proximity to the common femoral artery.
• The subject has an abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion.
• The subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to the initiation of the treatment for this study.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John R Laird, M.D.

Role: PRINCIPAL_INVESTIGATOR

U. C. Davis Medical Center

Locations

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

North Carolina Heart and Vascular

Raleigh, North Carolina, United States

Donald Guthrie Foundation

Sayre, Pennsylvania, United States

Univeristy of Texas Medical Branch

Galveston, Texas, United States

Swedish Health Services

Seattle, Washington, United States

Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH

Bad Krozingen, , Germany

Ev.Krankenhaus Königin Elisabeth

Berlin, , Germany

Praxis fur Interventionelle Angiologie

Kaiserslautern, , Germany

Universitaetsklinikum Leipzig

Leipzig, , Germany

Bonifatius Hospital

Lingen, , Germany

Auckland Hospital

Auckland, , New Zealand

Countries

United States; Germany; New Zealand

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BPV-12-001

Identifier Type: -

Identifier Source: org_study_id