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)

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.

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.