Overview

This trial is active, not recruiting.

Condition symptomatic vascular disease of the iliac arteries
Treatment formula™ 535 iliac balloon-expandable stent
Sponsor Cook
Start date March 2013
End date April 2015
Trial size 80 participants
Trial identifier NCT01804088, 09-023

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
formula™ 535 iliac balloon-expandable stent
Treatment of symptomatic vascular disease of the iliac arteries

Primary Outcomes

Measure
Freedom from major adverse events
time frame: 9 months

Secondary Outcomes

Measure
Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent)
time frame: Intraoperative
Rate of acute procedure success(i.e.,vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)
time frame: Postoperative until discharge (i.e., 0 to 4 days)
Rate of hemodynamic success(i.e., ABI or TBI improved above baseline)
time frame: 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)
time frame: 30 day
Rate of primary patency (i.e.,the proportion of patients, over time, that have had uninterrupted patency since the initial procedure)
time frame: 30 day, 9 month, 2 year, 3 year
Rate of functional status improvement based on walking impairment questionnaire
time frame: 30 day, 9 month, 2 year, 3 year
Rate of improvement in Rutherford Category (i.e., improvement above baseline)
time frame: 30 day, 9 month, 2 year, 3 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent
Principal investigator Patrick J. Geraghty, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Cook.