The GORE FREEDOM Study

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

W.L.Gore & Associates

ClinicalTrials.gov Identifier:

NCT01343667

First received: April 25, 2011

Last updated: March 26, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	April 25, 2011
Last Updated Date	March 26, 2013
Start Date ^ICMJE	April 2011
Estimated Primary Completion Date	April 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 28, 2011)	Evaluate the Major Adverse Event(MAE) rate with the commercial GORE Flow Reversal System and GORE Embolic FIlter through comparison with a performance goal MAE rate based on results from the Gore EMPiRE Clinical Study and the Gore EMBOLDEN Clinical Study [ Time Frame: Treatment through 30 day visit window ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: April 27, 2011)	Evaluate the Major Adverse Event(MAE) rate with the commercial GORE Flow Reversal System through comparison with a performance goal MAE rate based on results from the Gore EMPiRE Clinical Study [ Time Frame: Treatment through 30 day visit window ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT01343667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The GORE FREEDOM Study
Official Title ^ICMJE	The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	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
Intervention ^ICMJE	Procedure: Embolic Protection during carotid artery angioplasty and stenting Embolic protection by the GORE Flow Reversal System or the GORE Embolic Filter during carotid artery angioplasty and stenting Other Names: Neuro Protection System GORE Neuro Protection System Parodi NPS FRS PAES proximal protection embolic filter
Study Arm (s)	Carotid Artery Stenting with the GORE Flow Reversal System Intervention: Procedure: Embolic Protection during carotid artery angioplasty and stenting Carotid Artery Stenting with the GORE Embolic Filter Intervention: Procedure: Embolic Protection during carotid artery angioplasty and stenting
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	5000
Estimated Completion Date	June 2016
Estimated Primary Completion Date	April 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01343667
Other Study ID Numbers ^ICMJE	FRS 09-05
Has Data Monitoring Committee	No
Responsible Party	W.L.Gore & Associates
Study Sponsor ^ICMJE	W.L.Gore & Associates
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	W.L.Gore & Associates
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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