Status:
COMPLETED
FORMAT Clinical Study
Lead Sponsor:
Cook Group Incorporated
Conditions:
Symptomatic Vascular Disease of the Iliac Arteries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 arte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01804088
Start Date
March 1 2013
End Date
July 17 2017
Last Update
March 1 2018
Active Locations (12)
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1
Scripps Health
La Jolla, California, United States, 92037
2
CardioVascular Solutions Institute
Bradenton, Florida, United States, 34208
3
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32216
4
Coastal Vascular and Interventional
Pensacola, Florida, United States, 32503