Clinical trial NCT01804088: FORMAT Clinical Study
Official title: Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Vascular Disease of the Iliac Arteries
Keywords: Peripheral artery disease
Iliac arteries
Balloon-expandable stent
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-03-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from major adverse events
timeFrame: 9 months
Secondary outcomes:
measure: Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent)
timeFrame: Intraoperative
measure: Rate of acute procedure success(i.e.,vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)
timeFrame: Postoperative until discharge (i.e., 0 to 4 days)
measure: Rate of hemodynamic success(i.e., ABI or TBI improved above baseline)
timeFrame: 30 day, 9 month, 2 year, 3 year
measure: 30-day clinical success (i.e., vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)
timeFrame: 30 day
measure: Rate of primary patency (i.e.,the proportion of patients, over time, that have had uninterrupted patency since the initial procedure)
timeFrame: 30 day, 9 month, 2 year, 3 year
measure: Rate of functional status improvement based on walking impairment questionnaire
timeFrame: 30 day, 9 month, 2 year, 3 year
measure: Rate of improvement in Rutherford Category (i.e., improvement above baseline)
timeFrame: 30 day, 9 month, 2 year, 3 year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Bradenton
country: United States
facility: CardioVascular Solutions Institute
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Peoria
country: United States
facility: Peoria Radiology Associates
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health - Methodist Hospital
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New York
country: United States
facility: New York-Presbyterian/Weill Cornell Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Heart Research (Rex Hospital)
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
Study officials:
affiliation: Washington University School of Medicine
name: Patrick J. Geraghty, MD
role: PRINCIPAL_INVESTIGATOR
References: