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GORE Flow Reversal System and GORE Embolic Filter Extension Study (FREEDOM)

Primary Purpose

Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gore Flow Reversal System
Gore Embolic Filter
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis focused on measuring GORE Neuro Protection System, GORE Flow Reversal System, carotid artery stenosis, embolic protection device, reverse flow, proximal occlusion device, GNPS, Parodi, EMPiRE, distal embolization, minimizing risks of CAS, PAES, embolic filter

Eligibility Criteria

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

Inclusion Criteria:

  • Patient, or patient's legal representative, is able and willing to provide informed consent.
  • Patient must be at least 18 years of age or older.
  • Patient will be selected and treated according to the GORE Flow Reversal System Instructions for Use (IFU) or the GORE Embolic Filter IFU.

Exclusion Criteria:

  • Patient is contraindicated for the embolic protection device arm they are selected by the investigator to receive: Either Per the GORE Flow Reversal System IFU if the GORE Flow Reversal System is selected OR Per the GORE Embolic Filter IFU if the GORE Embolic Filter is selected

If the patient is contraindicated for both arms (devices) they may not be enrolled.

Sites / Locations

  • W.L. Gore and Associates, Inc
  • Hoag Memorial Hospital
  • University of California San Francisco
  • First Coast Cardiovascular Institute
  • Emory University
  • Kaiser FOundation Hospitals
  • Heart Care Research Foundation
  • Rockford Cardiovascular Associates
  • Indiana University
  • Ochsner Clinic
  • Johns Hopkins Hospital
  • Beth Israel Decaoness Medical Center
  • Harper Hospital
  • St John's Medical Center
  • St Joseph Mercy Hospital
  • Covenant Medical Center
  • St Anthony's Medical Center
  • St Joesph's Medical Center
  • Dartmouth Hitchcock Medical Center
  • Cooper University Hospital
  • Mercy Hospital
  • Mt Sinai Hospital
  • St Francis Hospital
  • Wake Heart Research
  • Forsyth Memorial Hospital
  • Cleveland Clinic Foundation
  • Riverside Methodist Hospital
  • Southwest General Health Center
  • Heritage Valley Health Network
  • Spirit Physician Services / Capital Cardiovascular Assoc
  • Drexel University
  • York Hospital
  • Medical University of South Carolina
  • Rapid City Regional Hospital
  • N. Central Heart Hospital
  • St Luke's Episcopal
  • Appleton Medical Cetner
  • University of Wisconsin
  • St Lukes Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

GFRS EPD

GEF EPD

Arm Description

Carotid artery stenting with Gore Flow Reversal System embolic protection device

Carotid artery stenting with Gore Embolic Filter embolic protection device

Outcomes

Primary Outcome Measures

Major Adverse Events (MAE)
Major Adverse Events include death, stroke and myocardial infarction

Secondary Outcome Measures

Full Information

First Posted
April 25, 2011
Last Updated
January 22, 2016
Sponsor
W.L.Gore & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT01343667
Brief Title
GORE Flow Reversal System and GORE Embolic Filter Extension Study
Acronym
FREEDOM
Official Title
The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
Detailed Description
Physicians will have the opportunity to select which embolic protection device, the GORE Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting procedure. This study is not designed to compare study endpoints between the two treatment arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Pathological Conditions, Anatomical
Keywords
GORE Neuro Protection System, GORE Flow Reversal System, carotid artery stenosis, embolic protection device, reverse flow, proximal occlusion device, GNPS, Parodi, EMPiRE, distal embolization, minimizing risks of CAS, PAES, embolic filter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1397 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GFRS EPD
Arm Type
Other
Arm Description
Carotid artery stenting with Gore Flow Reversal System embolic protection device
Arm Title
GEF EPD
Arm Type
Other
Arm Description
Carotid artery stenting with Gore Embolic Filter embolic protection device
Intervention Type
Device
Intervention Name(s)
Gore Flow Reversal System
Other Intervention Name(s)
Neuro Protection System, GORE Neuro Protection System, Parodi, NPS, FRS, PAES, proximal protection
Intervention Description
Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
Intervention Type
Device
Intervention Name(s)
Gore Embolic Filter
Other Intervention Name(s)
embolic filter, distal protection
Intervention Description
Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
Primary Outcome Measure Information:
Title
Major Adverse Events (MAE)
Description
Major Adverse Events include death, stroke and myocardial infarction
Time Frame
Onset from start of index procedure to 30-day follow-up assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient, or patient's legal representative, is able and willing to provide informed consent. Patient must be at least 18 years of age or older. Patient will be selected and treated according to the GORE Flow Reversal System Instructions for Use (IFU) or the GORE Embolic Filter IFU. Exclusion Criteria: Patient is contraindicated for the embolic protection device arm they are selected by the investigator to receive: Either Per the GORE Flow Reversal System IFU if the GORE Flow Reversal System is selected OR Per the GORE Embolic Filter IFU if the GORE Embolic Filter is selected If the patient is contraindicated for both arms (devices) they may not be enrolled.
Facility Information:
Facility Name
W.L. Gore and Associates, Inc
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
First Coast Cardiovascular Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Kaiser FOundation Hospitals
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Heart Care Research Foundation
City
Mokena
State/Province
Illinois
ZIP/Postal Code
60488
Country
United States
Facility Name
Rockford Cardiovascular Associates
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Beth Israel Decaoness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Harper Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St John's Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
St Joseph Mercy Hospital
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Covenant Medical Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
St Anthony's Medical Center
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
St Joesph's Medical Center
City
St Louis
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Mercy Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14220
Country
United States
Facility Name
Mt Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
St Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Wake Heart Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
26610
Country
United States
Facility Name
Forsyth Memorial Hospital
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Southwest General Health Center
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Heritage Valley Health Network
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Spirit Physician Services / Capital Cardiovascular Assoc
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
N. Central Heart Hospital
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
St Luke's Episcopal
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Appleton Medical Cetner
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
St Lukes Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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GORE Flow Reversal System and GORE Embolic Filter Extension Study

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