FORMAT Clinical Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 2013
End Date:July 17, 2017

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Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent

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
We found this trial at
12
sites
Kingsport, Tennessee 37660
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Kingsport, TN
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Bradenton, Florida 34208
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Bradenton, FL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Columbus, Ohio 43214
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Columbus, OH
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Jacksonville, Florida 32216
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Jacksonville, FL
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La Jolla, California 92037
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from
La Jolla, CA
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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New York, NY
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Pensacola, Florida 32204
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Pensacola, FL
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108 Southwest Madison Avenue
Peoria, Illinois 61602
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from
Peoria, IL
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Raleigh, North Carolina 27610
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from
Raleigh, NC
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