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

W.L. Gore & Associates

Status: Completed

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

Treatments: Device: Gore Embolic Filter; Device: Gore Flow Reversal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01343667

FRS 09-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,397 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,397 participants in 2 patient groups

GFRS EPD

Other group

Description:

Carotid artery stenting with Gore Flow Reversal System embolic protection device

Treatment:

Device: Gore Flow Reversal System

GEF EPD

Other group

Description:

Carotid artery stenting with Gore Embolic Filter embolic protection device

Treatment:

Device: Gore Embolic Filter