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FORMAT Clinical Study

Primary Purpose

Symptomatic Vascular Disease of the Iliac Arteries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Formula™ 535 Iliac Balloon-Expandable Stent
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Vascular Disease of the Iliac Arteries focused on measuring Peripheral artery disease, Iliac arteries, Balloon-expandable stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Health
  • CardioVascular Solutions Institute
  • First Coast Cardiovascular Institute
  • Coastal Vascular and Interventional
  • Peoria Radiology Associates
  • Indiana University Health - Methodist Hospital
  • University of Louisville
  • New York-Presbyterian/Weill Cornell Medical Center
  • Wake Heart Research (Rex Hospital)
  • Cleveland Clinic Foundation
  • Ohio Health Research Institute
  • Wellmont Holston Valley Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stent

Arm Description

Outcomes

Primary Outcome Measures

Freedom from major adverse events

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2013
Last Updated
February 27, 2018
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01804088
Brief Title
FORMAT Clinical Study
Official Title
Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Vascular Disease of the Iliac Arteries
Keywords
Peripheral artery disease, Iliac arteries, Balloon-expandable stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Formula™ 535 Iliac Balloon-Expandable Stent
Intervention Description
Treatment of symptomatic vascular disease of the iliac arteries
Primary Outcome Measure Information:
Title
Freedom from major adverse events
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent)
Time Frame
Intraoperative
Title
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)
Title
Rate of hemodynamic success(i.e., ABI or TBI improved above baseline)
Time Frame
30 day, 9 month, 2 year, 3 year
Title
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
Title
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
Title
Rate of functional status improvement based on walking impairment questionnaire
Time Frame
30 day, 9 month, 2 year, 3 year
Title
Rate of improvement in Rutherford Category (i.e., improvement above baseline)
Time Frame
30 day, 9 month, 2 year, 3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J. Geraghty, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
CardioVascular Solutions Institute
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
First Coast Cardiovascular Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Coastal Vascular and Interventional
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Peoria Radiology Associates
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Indiana University Health - Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
New York-Presbyterian/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Wake Heart Research (Rex Hospital)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States

12. IPD Sharing Statement

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FORMAT Clinical Study

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