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

• 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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Results First Submitted: 2015-12-15
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-22
• Last Update Submitted: 2016-01-22
• Results First Posted: 2016-02-19
• Last Update Posted: 2016-02-19

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

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

Trial Locations

Locations (39)

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

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