GORE Flow Reversal System and GORE Embolic Filter Extension Study

Not Applicable

Completed

Conditions: Central Nervous System Diseases
Carotid Stenosis
Constriction, Pathologic
Cerebrovascular Disorders
Carotid Artery Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Brain Diseases
Pathological Conditions, Anatomical
Vascular Diseases

Interventions: Device: Gore Flow Reversal System
Device: Gore Embolic Filter

Registration Number: NCT01343667

Lead Sponsor: W.L.Gore & Associates

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1397

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GFRS EPD	Gore Flow Reversal System	Carotid artery stenting with Gore Flow Reversal System embolic protection device
GEF EPD	Gore Embolic Filter	Carotid artery stenting with Gore Embolic Filter embolic protection device

Primary Outcome Measures

Name	Time	Method
Major Adverse Events (MAE)	Onset from start of index procedure to 30-day follow-up assessment	Major Adverse Events include death, stroke and myocardial infarction

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (39): Appleton Medical Cetner
🇺🇸
Appleton, Wisconsin, United States
Kaiser FOundation Hospitals
🇺🇸
Honolulu, Hawaii, United States
Drexel University
🇺🇸
Philadelphia, Pennsylvania, United States
University of California San Francisco
🇺🇸
San Francisco, California, United States
Hoag Memorial Hospital
🇺🇸
Newport Beach, California, United States
Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Harper Hospital
🇺🇸
Detroit, Michigan, United States
St Joseph Mercy Hospital
🇺🇸
Pontiac, Michigan, United States
Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
W.L. Gore and Associates, Inc
🇺🇸
Flagstaff, Arizona, United States
Cooper University Hospital
🇺🇸
Camden, New Jersey, United States
Southwest General Health Center
🇺🇸
Middleburg Heights, Ohio, United States
Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Ochsner Clinic
🇺🇸
New Orleans, Louisiana, United States
Beth Israel Decaoness Medical Center
🇺🇸
Boston, Massachusetts, United States
St Anthony's Medical Center
🇺🇸
St Louis, Missouri, United States
St Francis Hospital
🇺🇸
Roslyn, New York, United States
University of Wisconsin
🇺🇸
Madison, Wisconsin, United States
Wake Heart Research
🇺🇸
Raleigh, North Carolina, United States
Heart Care Research Foundation
🇺🇸
Mokena, Illinois, United States
Mt Sinai Hospital
🇺🇸
New York, New York, United States
Rockford Cardiovascular Associates
🇺🇸
Rockford, Illinois, United States
St John's Medical Center
🇺🇸
Detroit, Michigan, United States
First Coast Cardiovascular Institute
🇺🇸
Jacksonville, Florida, United States
St Joesph's Medical Center
🇺🇸
St Louis, Missouri, United States
Covenant Medical Center
🇺🇸
Saginaw, Michigan, United States
Forsyth Memorial Hospital
🇺🇸
Winston Salem, North Carolina, United States
Spirit Physician Services / Capital Cardiovascular Assoc
🇺🇸
Camp Hill, Pennsylvania, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
York Hospital
🇺🇸
York, Pennsylvania, United States
Mercy Hospital
🇺🇸
Buffalo, New York, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Heritage Valley Health Network
🇺🇸
Beaver, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸
Rapid City, South Dakota, United States
N. Central Heart Hospital
🇺🇸
Sioux Falls, South Dakota, United States
St Luke's Episcopal
🇺🇸
Houston, Texas, United States
St Lukes Medical Center
🇺🇸
Milwaukee, Wisconsin, United States