FORMAT Clinical Study

Cook Group Incorporated80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Symptomatic Vascular Disease of the Iliac Arteries

Interventions

Formula™ 535 Iliac Balloon-Expandable StentDEVICE

Treatment of symptomatic vascular disease of the iliac arteries

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Scripps Health

La Jolla, California, United States

CardioVascular Solutions Institute

Bradenton, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Freedom from major adverse events

Time frame: 9 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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