Clinical Investigation Plan Of The Cook Formula™ 535 Iliac Balloon-Expandable Stent (FORMAT Clinical Study) (Protocol 09-023-01)

Trial ID:
IRB-13-6097
Curtiss Stinis
The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.

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