The Complete® Self-Expanding Stent and Stent Delivery System Registry

The study is being conducted to collect the 30-day safety data on the stent delivery system
for all subjects enrolled into the study (with a minimum of 50 subjects enrolled) as well as
the long-term 9-month safety and efficacy data on all subjects enrolled (with a minimum of
10 subjects enrolled into the study having the 120mm length stent implanted).

Inclusion Criteria:

- The lesion(s) is either de-novo or restenotic in nature, located in either the common
iliac artery or the external iliac artery and is >50% stenosed

- Target vessel reference diameter ≥ 4.5 mm and ≤ 9.5 and can accommodate stent
diameters of 6.0 - 10.0mm

- Subject is either asymptomatic with a lesion stenosis ≥70% or symptomatic with a
lesion stenosis ≥50% with an Ankle Brachial Index (ABI) < 0.90 or Toe Brachial Index
(TBI) <0.80 or an abnormal Pulse Volume Recording (PVR);

- Total lesion length is < 110 mm;

Exclusion Criteria:

- Excessive Peripheral Vascular Disease (PVD), unresolved fresh thrombus or tortuosity
or a target lesion/vessel that is heavily calcified ;

- Tissue loss in the extremity: category 5 or 6 on the Rutherford scale;

- Target lesion has a previous stent, or is within a prosthetic vascular bypass graft
or within 1 cm of a graft anastomosis;

- Target lesion is within an aneurysm or associated with an aneurysm in the vessel
segment proximal or distal to the target lesion;

- Lesion requires treatment with a non-standard device associated with Percutaneous
Transluminal Angioplasty (PTA) prior to stent placement;

- Inadequate distal run-off;

- Planned interventional procedure or vascular surgery to target vessel within 30 days
pre- or post-index iliac procedure;

- History of bleeding diatheses or coagulopathy or will refuse blood transfusions;

- Platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or White Blood Count (WBC)
<3,000 cells/mm3;

- Creatinine >2.0 mg/dl;

- Participation in another investigational device or drug study and has not completed
the primary endpoint(s) follow-up phase of that study at least 30 days prior to
enrollment in this trial or the subject has previously been enrolled in this
Registry;