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

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.