Symptomatic Vascular Disease of the Iliac Arteries Clinical Trial
Official title:
Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent
| Verified date | February 2018 |
| Source | Cook Group Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | July 17, 2017 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | CardioVascular Solutions Institute | Bradenton | Florida |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Ohio Health Research Institute | Columbus | Ohio |
| United States | Indiana University Health - Methodist Hospital | Indianapolis | Indiana |
| United States | First Coast Cardiovascular Institute | Jacksonville | Florida |
| United States | Wellmont Holston Valley Medical Center | Kingsport | Tennessee |
| United States | Scripps Health | La Jolla | California |
| United States | University of Louisville | Louisville | Kentucky |
| United States | New York-Presbyterian/Weill Cornell Medical Center | New York | New York |
| United States | Coastal Vascular and Interventional | Pensacola | Florida |
| United States | Peoria Radiology Associates | Peoria | Illinois |
| United States | Wake Heart Research (Rex Hospital) | Raleigh | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Cook Group Incorporated |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Freedom from major adverse events | 9 months | ||
| Secondary | Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent) | Intraoperative | ||
| Secondary | 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) | ||
| Secondary | Rate of hemodynamic success(i.e., ABI or TBI improved above baseline) | 30 day, 9 month, 2 year, 3 year | ||
| Secondary | 30-day clinical success (i.e., vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events) | 30 day | ||
| Secondary | 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 | ||
| Secondary | Rate of functional status improvement based on walking impairment questionnaire | 30 day, 9 month, 2 year, 3 year | ||
| Secondary | Rate of improvement in Rutherford Category (i.e., improvement above baseline) | 30 day, 9 month, 2 year, 3 year |