FORMAT Clinical Study

Cook Group

Status

Completed

Conditions

Symptomatic Vascular Disease of the Iliac Arteries

Treatments

Device: Formula™ 535 Iliac Balloon-Expandable Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT01804088

09-023

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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