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

C. R. Bard

Status

Completed

Conditions

Peripheral Vascular Disease

Peripheral Artery Disease

Arterial Occlusive Disease

Treatments

Procedure: Percutaneous transluminal angioplasty (PTA)

Device: LIFESTREAM™ covered stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT02228564

BPV-12-001

Details and patient eligibility

About

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.

Enrollment

155 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

CLINICAL 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.

ANGIOGRAPHIC INCLUSION CRITERIA:

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.

CLINICAL 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.

ANGIOGRAPHIC EXCLUSION CRITERIA:

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.