Clinical trial NCT01343667: GORE Flow Reversal System and GORE Embolic Filter Extension Study
Official title: The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: 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
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 1397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Events (MAE)
timeFrame: Onset from start of index procedure to 30-day follow-up assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: W.L. Gore and Associates, Inc
state: Arizona
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Honolulu
country: United States
facility: Kaiser FOundation Hospitals
state: Hawaii
city: Mokena
country: United States
facility: Heart Care Research Foundation
state: Illinois
city: Rockford
country: United States
facility: Rockford Cardiovascular Associates
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Decaoness Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Harper Hospital
state: Michigan
city: Detroit
country: United States
facility: St John's Medical Center
state: Michigan
city: Pontiac
country: United States
facility: St Joseph Mercy Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
city: St Louis
country: United States
facility: St Anthony's Medical Center
state: Missouri
city: St Louis
country: United States
facility: St Joesph's Medical Center
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Buffalo
country: United States
facility: Mercy Hospital
state: New York
city: New York
country: United States
facility: Mt Sinai Hospital
state: New York
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
city: Raleigh
country: United States
facility: Wake Heart Research
state: North Carolina
city: Winston Salem
country: United States
facility: Forsyth Memorial Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest General Health Center
state: Ohio
city: Beaver
country: United States
facility: Heritage Valley Health Network
state: Pennsylvania
city: Camp Hill
country: United States
facility: Spirit Physician Services / Capital Cardiovascular Assoc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: N. Central Heart Hospital
state: South Dakota
city: Houston
country: United States
facility: St Luke's Episcopal
state: Texas
city: Appleton
country: United States
facility: Appleton Medical Cetner
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: St Lukes Medical Center
state: Wisconsin
Study officials:
References: