FORMAT Clinical Study

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

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 Overview

• Status: Completed
• Conditions: Symptomatic Vascular Disease of the Iliac Arteries
• Intervention / Treatment: Device: Formula™ 535 Iliac Balloon-Expandable Stent

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Health
  • Florida
    • Bradenton, Florida, United States, 34208
      • CardioVascular Solutions Institute
    • Jacksonville, Florida, United States, 32216
      • First Coast Cardiovascular Institute
    • Pensacola, Florida, United States, 32503
      • Coastal Vascular and Interventional
  • Illinois
    • Peoria, Illinois, United States, 61602
      • Peoria Radiology Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health - Methodist Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • New York
    • New York, New York, United States, 10065
      • New York-Presbyterian/Weill Cornell Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Wake Heart Research (Rex Hospital)
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom from major adverse events	9 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cook Group Incorporated
• Investigators: Principal Investigator: Patrick J. Geraghty, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): July 17, 2017

Study Registration Dates

• First Submitted: March 1, 2013
• First Submitted That Met QC Criteria: March 1, 2013
• First Posted (Estimate): March 5, 2013

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Peripheral artery disease; Iliac arteries; Balloon-expandable stent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 09-023