The GORE FREEDOM Study - Full Text View

Purpose

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.

Condition	Intervention
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	Procedure: Embolic Protection during carotid artery angioplasty and stenting

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Brain Diseases Carotid Artery Disease Neurologic Diseases Vascular Diseases

U.S. FDA Resources

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:

Evaluate the Major Adverse Event(MAE) rate with the commercial GORE Flow Reversal System and GORE Embolic FIlter through comparison with a performance goal MAE rate based on results from the Gore EMPiRE Clinical Study and the Gore EMBOLDEN Clinical Study [ Time Frame: Treatment through 30 day visit window ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	5000
Study Start Date:	April 2011
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Carotid Artery Stenting with the GORE Flow Reversal System	Procedure: Embolic Protection during carotid artery angioplasty and stenting Embolic protection by the GORE Flow Reversal System or the GORE Embolic Filter during carotid artery angioplasty and stenting Other Names: Neuro Protection System GORE Neuro Protection System Parodi NPS FRS PAES proximal protection embolic filter
Carotid Artery Stenting with the GORE Embolic Filter	Procedure: Embolic Protection during carotid artery angioplasty and stenting Embolic protection by the GORE Flow Reversal System or the GORE Embolic Filter during carotid artery angioplasty and stenting Other Names: Neuro Protection System GORE Neuro Protection System Parodi NPS FRS PAES proximal protection embolic filter

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343667

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Locations

United States, Arizona
W.L. Gore and Associates, Inc
Flagstaff, Arizona, United States, 86001
United States, California
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
University of California San Francisco
San Francisco, California, United States, 94143
United States, Florida
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32216
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Kaiser FOundation Hospitals
Honolulu, Hawaii, United States, 96819
United States, Illinois
Heart Care Research Foundation
Mokena, Illinois, United States, 60488
Rockford Cardiovascular Associates
Rockford, Illinois, United States, 61107
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Beth Israel Decaoness Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Harper Hospital
Detroit, Michigan, United States, 48201
St John's Medical Center
Detroit, Michigan, United States, 48236
St Joseph Mercy Hospital
Pontiac, Michigan, United States, 48341
Covenant Medical Center
Saginaw, Michigan, United States, 48602
United States, Missouri
St Joesph's Medical Center
St Louis, Missouri, United States, 64114
St Anthony's Medical Center
St Louis, Missouri, United States, 63128
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Mercy Hospital
Buffalo, New York, United States, 14220
Mt Sinai Hospital
New York, New York, United States, 10029
St Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Wake Heart Research
Raleigh, North Carolina, United States, 26610
Forsyth Memorial Hospital
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
Heritage Valley Health Network
Beaver, Pennsylvania, United States, 15009
Spirit Physician Services / Capital Cardiovascular Assoc
Camp Hill, Pennsylvania, United States, 17011
Drexel University
Philadelphia, Pennsylvania, United States, 19102
York Hospital
York, Pennsylvania, United States, 17405
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
N. Central Heart Hospital
Sioux Falls, South Dakota, United States, 57108
United States, Texas
St Luke's Episcopal
Houston, Texas, United States, 77030
United States, Wisconsin
Appleton Medical Cetner
Appleton, Wisconsin, United States, 54911
University of Wisconsin
Madison, Wisconsin, United States, 53792
St Lukes Medical Center
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

W.L.Gore & Associates

More Information

No publications provided

Responsible Party:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT01343667 History of Changes
Other Study ID Numbers:	FRS 09-05
Study First Received:	April 25, 2011
Last Updated:	March 26, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by W.L.Gore & Associates:

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

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Carotid Stenosis
Central Nervous System Diseases

Cerebrovascular Disorders
Constriction, Pathologic
Nervous System Diseases
Vascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013