FORMAT Clinical Study

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent

Conditions
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Symptomatic Vascular Disease of the Iliac Arteries

Intervention / Treatment
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* Device: Formula™ 535 Iliac Balloon-Expandable Stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stent<br> | Device: Formula™ 535 Iliac Balloon-Expandable Stent<br>* Treatment of symptomatic vascular disease of the iliac arteries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from major adverse events |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent) |  | Intraoperative | 
| 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 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral artery disease, Iliac arteries, Balloon-expandable stent