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

CLINICAL INCLUSION CRITERIA:

• The subject provides written informed consent using an Informed Consent Form approvedby 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 lifespansufficient 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 withan 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/orsuperficial femoral artery (SFA) in the target limb.

CLINICAL EXCLUSION CRITERIA:

• The subject is unable or unwilling to provide written informed consent or to conformto 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 withtissue 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 3months 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 thrombolyticmedications required per the protocol.

• The subject has a known allergy or sensitivity to contrast media, which cannot beadequately pre-medicated.

• The subject had a prior vascular intervention within 30 days before or planned forwithin 30 days after the index procedure.

• The subject has another medical condition, which may cause him/her to be non-compliantwith the protocol, confound the data interpretation, or is associated with a lifeexpectancy insufficient to allow for the completion of study procedures and follow-up.

• The subject is currently participating in an investigational drug, biologic, oranother device study. ANGIOGRAPHIC EXCLUSION CRITERIA:

• The subject has extensive peripheral vascular disease, which in the opinion of theInvestigator, would preclude safe insertion of an introducer sheath. The ipsilateralcommon femoral artery should be patent (< 50% stenosis).

• The target lesion requires treatment other than angioplasty to facilitate subjectdevice delivery.

• The subject has severe calcification of the target lesion, preventing inflation of PTAballoon.

• 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 thatsuccessful treatment of the lesion would require the subject device to cross/occludethe side branch.

• The target lesion located in the distal external iliac artery such that successfultreatment of the lesion would require the subject device to cross/occlude sidebranches or be exposed to compressive forces associated with the close proximity tothe common femoral artery.

• The subject has an abdominal aortic aneurysm (AAA) contiguous to the iliac arterytarget lesion.

• The subject has a pre-existing target iliac artery aneurysm or perforation ordissection of the target iliac artery prior to the initiation of the treatment forthis study.