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 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.