FORMAT Clinical Study
- Conditions
- Symptomatic Vascular Disease of the Iliac Arteries
- Interventions
- Device: Formula™ 535 Iliac Balloon-Expandable Stent
- Registration Number
- NCT01804088
- Lead Sponsor
- Cook Group Incorporated
- 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 arteries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stent Formula™ 535 Iliac Balloon-Expandable Stent -
- Primary Outcome Measures
Name Time Method Freedom from major adverse events 9 months
- Secondary Outcome Measures
Name Time Method Rate of functional status improvement based on walking impairment questionnaire 30 day, 9 month, 2 year, 3 year Rate of improvement in Rutherford Category (i.e., improvement above baseline) 30 day, 9 month, 2 year, 3 year Rate of acute procedure success(i.e.,vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events) Postoperative until discharge (i.e., 0 to 4 days) 30-day clinical success (i.e., vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events) 30 day Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent) Intraoperative Rate of hemodynamic success(i.e., ABI or TBI improved above baseline) 30 day, 9 month, 2 year, 3 year Rate of primary patency (i.e.,the proportion of patients, over time, that have had uninterrupted patency since the initial procedure) 30 day, 9 month, 2 year, 3 year
Trial Locations
- Locations (12)
CardioVascular Solutions Institute
🇺🇸Bradenton, Florida, United States
New York-Presbyterian/Weill Cornell Medical Center
🇺🇸New York, New York, United States
Indiana University Health - Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Peoria Radiology Associates
🇺🇸Peoria, Illinois, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Wake Heart Research (Rex Hospital)
🇺🇸Raleigh, North Carolina, United States
Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Scripps Health
🇺🇸La Jolla, California, United States
First Coast Cardiovascular Institute
🇺🇸Jacksonville, Florida, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Coastal Vascular and Interventional
🇺🇸Pensacola, Florida, United States