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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	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
Interventions:	Device: Gore Flow Reversal System; Device: Gore Embolic Filter

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
GFRS EPD	Carotid artery stenting with Gore Flow Reversal System Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
GEF EPD	Carotid artery stenting with Gore Embolic Filter Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting

Participant Flow:   Overall Study

	GFRS EPD	GEF EPD
STARTED	425	972
COMPLETED	413	916
NOT COMPLETED	12	56

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Enrolled Subjects

Reporting Groups

	Description
GFRS EPD	Carotid artery stenting with Gore Flow Reversal System Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
GEF EPD	Carotid artery stenting with Gore Embolic Filter Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
Total	Total of all reporting groups

Baseline Measures

	GFRS EPD	GEF EPD	Total
Overall Participants Analyzed; [Units: Participants]	425	972	1397
Age; [Units: Years]; Mean (Standard Deviation)	72.7 (8.7)	73.0 (9.4)	72.9 (9.2)
Gender; [Units: Participants]
Female	139	587	726
Male	286	385	671
Ethnicity (NIH/OMB); [Units: Participants]
Hispanic or Latino	11	16	27
Not Hispanic or Latino	414	955	1369
Unknown or Not Reported	0	1	1
Race/Ethnicity, Customized [1]; [Units: Participants]
American Indian or Alaska Native	8	9	17
Asian	7	8	15
Black or African American	26	56	82
Native Hawaiian or Other Pacific Islander	2	1	3
White or Caucasian	381	901	1282
Not Reported	2	1	3
[1] This measure is structured as a "check all that apply" field on the Case Report Form. Thus, the race categories are not mutually exclusive, except that "Not Reported" is mutually exclusive with the others. Because of this, the sum of the individual category counts is greater than the overall number of participants.

  Outcome Measures

1. Primary:

Major Adverse Events (MAE) [ Time Frame: Onset from start of index procedure to 30-day follow-up assessment ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: Bryan Randall, Clinical Biostatistician
Organization: W. L. Gore & Associates
phone: 928-864-4832
e-mail: BRandall@WLGore.com

Responsible Party:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT01343667 History of Changes
Other Study ID Numbers:	FRS 09-05
First Submitted:	April 25, 2011
First Posted:	April 28, 2011
Results First Submitted:	December 15, 2015
Results First Posted:	February 19, 2016
Last Update Posted:	February 19, 2016