Symptomatic Vascular Disease of the Iliac Arteries
Conditions
Keywords
Peripheral artery disease, Iliac arteries, Balloon-expandable stent
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.
Interventions
DEVICEFormula™ 535 Iliac Balloon-Expandable Stent
Treatment of symptomatic vascular disease of the iliac arteries
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from major adverse events | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Rate of hemodynamic success(i.e., ABI or TBI improved above baseline) | 30 day, 9 month, 2 year, 3 year |
| 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 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 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 |
Countries
United States
Outcome results
None listed