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Completed

NCT Number: NCT01343667

GORE Flow Reversal System and GORE Embolic Filter Extension Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

W.L. Gore and Associates, Inc, Flagstaff, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gore Flow Reversal System

Device

Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting

Other names: Neuro Protection System, GORE Neuro Protection System, Parodi, NPS, FRS, PAES, proximal protection

Gore Embolic Filter

Device

Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting

Other names: embolic filter, distal protection

Primary outcomes

  1. Major Adverse Events (MAE)

    Time frame: Onset from start of index procedure to 30-day follow-up assessment

    Major Adverse Events include death, stroke and myocardial infarction

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes

Acronym: FREEDOM

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 28, 2011
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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