GORE Flow Reversal System and GORE Embolic Filter Extension Study

Completed · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01343667

Run by

W.L.Gore & Associates

People needed

1397

Starts

2011-04-01

Expected to finish

2014-01-01

Last updated by the study team

2016-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• W.L. Gore and Associates, Inc — Flagstaff, Arizona, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• University of California San Francisco — San Francisco, California, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Kaiser FOundation Hospitals — Honolulu, Hawaii, United States
• Heart Care Research Foundation — Mokena, Illinois, United States
• Rockford Cardiovascular Associates — Rockford, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Beth Israel Decaoness Medical Center — Boston, Massachusetts, United States
• Harper Hospital — Detroit, Michigan, United States
• St John's Medical Center — Detroit, Michigan, United States
• St Joseph Mercy Hospital — Pontiac, Michigan, United States
• Covenant Medical Center — Saginaw, Michigan, United States
• St Anthony's Medical Center — St Louis, Missouri, United States
• St Joesph's Medical Center — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Mercy Hospital — Buffalo, New York, United States
• Mt Sinai Hospital — New York, New York, United States
• St Francis Hospital — Roslyn, New York, United States
• Wake Heart Research — Raleigh, North Carolina, United States
• Forsyth Memorial Hospital — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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