GORE Flow Reversal System and GORE Embolic Filter Extension Study

Cardiovascular Diseases Clinical Trial

— FREEDOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343667
• Other study ID #: FRS 09-05
• Status: Completed
• Phase: N/A
• First received: April 25, 2011
• Last updated: January 22, 2016
• Start date: April 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2016
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1397
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Gore Flow Reversal System
Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
• Gore Embolic Filter
Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting

Locations

Country	Name	City	State
United States	Appleton Medical Cetner	Appleton	Wisconsin
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Heritage Valley Health Network	Beaver	Pennsylvania
United States	Beth Israel Decaoness Medical Center	Boston	Massachusetts
United States	Mercy Hospital	Buffalo	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Spirit Physician Services / Capital Cardiovascular Assoc	Camp Hill	Pennsylvania
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Harper Hospital	Detroit	Michigan
United States	St John's Medical Center	Detroit	Michigan
United States	W.L. Gore and Associates, Inc	Flagstaff	Arizona
United States	Kaiser FOundation Hospitals	Honolulu	Hawaii
United States	St Luke's Episcopal	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Wisconsin	Madison	Wisconsin
United States	Southwest General Health Center	Middleburg Heights	Ohio
United States	St Lukes Medical Center	Milwaukee	Wisconsin
United States	Heart Care Research Foundation	Mokena	Illinois
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Mt Sinai Hospital	New York	New York
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Drexel University	Philadelphia	Pennsylvania
United States	St Joseph Mercy Hospital	Pontiac	Michigan
United States	Wake Heart Research	Raleigh	North Carolina
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Rockford Cardiovascular Associates	Rockford	Illinois
United States	St Francis Hospital	Roslyn	New York
United States	Covenant Medical Center	Saginaw	Michigan
United States	University of California San Francisco	San Francisco	California
United States	N. Central Heart Hospital	Sioux Falls	South Dakota
United States	St Anthony's Medical Center	St Louis	Missouri
United States	St Joesph's Medical Center	St Louis	Missouri
United States	Forsyth Memorial Hospital	Winston Salem	North Carolina
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events (MAE)	Major Adverse Events include death, stroke and myocardial infarction	Onset from start of index procedure to 30-day follow-up assessment	Yes