FORMAT Clinical Study

Inclusion Criteria:

- Up to two documented common or external iliac artery lesions (one on each side), with
>50% diameter stenosis, suitable for stenting

- iliac artery reference vessel diameter of 5-10 mm

- Rutherford Category 1, 2, 3, or 4.

Exclusion Criteria:

- Less than 18 years of age

- lesion site <10 or >100 mm in length

- external iliac artery lesion visually estimated to be 100% occluded

- presence of infrarenal aortic aneurysm >4 cm (treated or untreated)

- presence of any aneurysm (treated or untreated) within target vessel

- significant stenosis (>50%) or occlusion of inflow tract (infrarenal aortic lesions)
not successfully treated before this procedure (success is measured as < 30% residual
stenosis)

- absence of at least one patent runoff vessel with ≤ 50% stenosis throughout its course
(i.e., confirmed in-line patency to the level of the foot)

- angiographically evident thrombus within the target vessel (treated or untreated)

- lesion is in an iliac artery that has been previously stented