FREEDOM: GORE Flow Reversal System and GORE Embolic Filter Extension Study

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01343667
• Collaborator: (none)
• Enrollment: 1,397
• Locations: 39
• Arms: 2
• Duration (Months): 33.1
• Patients Per Site: 35.8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Device: Gore Flow Reversal System; Device: Gore Embolic Filter	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1397 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: GFRS EPD Carotid artery stenting with Gore Flow Reversal System embolic protection device	Device: Gore Flow Reversal System; 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
Other: GEF EPD Carotid artery stenting with Gore Embolic Filter embolic protection device	Device: Gore Embolic Filter; Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting; Other Names: embolic filter distal protection

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	W.L. Gore and Associates, Inc	Flagstaff	Arizona	United States	86001
2	Hoag Memorial Hospital	Newport Beach	California	United States	92663
3	University of California San Francisco	San Francisco	California	United States	94143
4	First Coast Cardiovascular Institute	Jacksonville	Florida	United States	32216
5	Emory University	Atlanta	Georgia	United States	30322
6	Kaiser FOundation Hospitals	Honolulu	Hawaii	United States	96819
7	Heart Care Research Foundation	Mokena	Illinois	United States	60488
8	Rockford Cardiovascular Associates	Rockford	Illinois	United States	61107
9	Indiana University	Indianapolis	Indiana	United States	46202
10	Ochsner Clinic	New Orleans	Louisiana	United States	70121
11	Johns Hopkins Hospital	Baltimore	Maryland	United States	21205
12	Beth Israel Decaoness Medical Center	Boston	Massachusetts	United States	02215
13	Harper Hospital	Detroit	Michigan	United States	48201
14	St John's Medical Center	Detroit	Michigan	United States	48236
15	St Joseph Mercy Hospital	Pontiac	Michigan	United States	48341
16	Covenant Medical Center	Saginaw	Michigan	United States	48602
17	St Anthony's Medical Center	St Louis	Missouri	United States	63128
18	St Joesph's Medical Center	St Louis	Missouri	United States	64114
19	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
20	Cooper University Hospital	Camden	New Jersey	United States	08103
21	Mercy Hospital	Buffalo	New York	United States	14220
22	Mt Sinai Hospital	New York	New York	United States	10029
23	St Francis Hospital	Roslyn	New York	United States	11576
24	Wake Heart Research	Raleigh	North Carolina	United States	26610
25	Forsyth Memorial Hospital	Winston Salem	North Carolina	United States	27103
26	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
27	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
28	Southwest General Health Center	Middleburg Heights	Ohio	United States	44130
29	Heritage Valley Health Network	Beaver	Pennsylvania	United States	15009
30	Spirit Physician Services / Capital Cardiovascular Assoc	Camp Hill	Pennsylvania	United States	17011
31	Drexel University	Philadelphia	Pennsylvania	United States	19102
32	York Hospital	York	Pennsylvania	United States	17405
33	Medical University of South Carolina	Charleston	South Carolina	United States	29425
34	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
35	N. Central Heart Hospital	Sioux Falls	South Dakota	United States	57108
36	St Luke's Episcopal	Houston	Texas	United States	77030
37	Appleton Medical Cetner	Appleton	Wisconsin	United States	54911
38	University of Wisconsin	Madison	Wisconsin	United States	53792
39	St Lukes Medical Center	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT01343667
• Other Study ID Numbers: FRS 09-05
• First Posted: Apr 28, 2011
• Last Update Posted: Feb 19, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by W.L.Gore & Associates: GORE Neuro Protection System; GORE Flow Reversal System; carotid artery stenosis; embolic protection device; reverse flow; proximal occlusion device; GNPS; Parodi; EMPiRE; distal embolization; minimizing risks of CAS; PAES; embolic filter
• Additional relevant MeSH terms: Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Carotid Stenosis; Cerebrovascular Disorders; Carotid Artery Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Constriction, Pathologic; Pathological Conditions, Anatomical

Study Results

Participant Flow

Arm/Group Title	GFRS EPD	GEF EPD
Arm/Group Description	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	Carotid artery stenting with Gore Embolic Filter Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
Period Title: Overall Study
STARTED	425	972
COMPLETED	413	916
NOT COMPLETED	12	56

Baseline Characteristics

Arm/Group Title	GFRS EPD	GEF EPD	Total
Arm/Group Description	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	Carotid artery stenting with Gore Embolic Filter Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting	Total of all reporting groups
Overall Participants	425	972	1397
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.7 (8.7)	73.0 (9.4)	72.9 (9.2)
Sex: Female, Male (Count of Participants)
Female	139 32.7%	587 60.4%	726 52%
Male	286 67.3%	385 39.6%	671 48%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 2.6%	16 1.6%	27 1.9%
Not Hispanic or Latino	414 97.4%	955 98.3%	1369 98%
Unknown or Not Reported	0 0%	1 0.1%	1 0.1%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	8 1.9%	9 0.9%	17 1.2%
Asian	7 1.6%	8 0.8%	15 1.1%
Black or African American	26 6.1%	56 5.8%	82 5.9%
Native Hawaiian or Other Pacific Islander	2 0.5%	1 0.1%	3 0.2%
White or Caucasian	381 89.6%	901 92.7%	1282 91.8%
Not Reported	2 0.5%	1 0.1%	3 0.2%

Outcome Measures

1. Primary Outcome

Title	Major Adverse Events (MAE)
Description	Major Adverse Events include death, stroke and myocardial infarction
Time Frame	Onset from start of index procedure to 30-day follow-up assessment

Outcome Measure Data

Analysis Population Description

Enrolled subjects with successful procedure and sufficient follow-up

Arm/Group Title	GFRS EPD	GEF EPD
Arm/Group Description	Carotid artery stenting with Gore Flow Reversal System embolic protection device Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting	Carotid artery stenting with Gore Embolic Filter embolic protection device Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
Measure Participants	386	864
Number [participants]	18 4.2%	36 3.7%

Adverse Events

Time Frame	30-day visit window
Adverse Event Reporting Description	The Major Adverse Event components are reported as individual Serious Adverse Events. No other adverse events were collected in this study, so the number of subjects affected by Other (Not Including Serious) Adverse Events is zero (0).
Arm/Group Title	GFRS EPD		GEF EPD
Arm/Group Description	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		Carotid artery stenting with Gore Embolic Filter Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
All Cause Mortality
	GFRS EPD		GEF EPD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	GFRS EPD		GEF EPD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/425 (4.2%)		36/972 (3.7%)
Cardiac disorders
All Cause Death	2/425 (0.5%)	2	10/972 (1%)	10
Myocardial Infarction	6/425 (1.4%)	6	3/972 (0.3%)	3
Nervous system disorders
Stroke	14/425 (3.3%)	14	31/972 (3.2%)	31
Other (Not Including Serious) Adverse Events
	GFRS EPD		GEF EPD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/425 (0%)		0/972 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.