FORMAT Clinical Study

Completed · Not applicable

Conditions studied: Symptomatic Vascular Disease of the Iliac Arteries

In brief

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.

Key facts

Study ID

NCT01804088

Run by

Cook Group Incorporated

People needed

80

Starts

2013-03-01

Expected to finish

2017-07-17

Last updated by the study team

2018-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Scripps Health — La Jolla, California, United States
• CardioVascular Solutions Institute — Bradenton, Florida, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Coastal Vascular and Interventional — Pensacola, Florida, United States
• Peoria Radiology Associates — Peoria, Illinois, United States
• Indiana University Health - Methodist Hospital — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• New York-Presbyterian/Weill Cornell Medical Center — New York, New York, United States
• Wake Heart Research (Rex Hospital) — Raleigh, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.