Carotid StenosisFREEDOMNCT01343667
GORE Flow Reversal System and GORE Embolic Filter Extension Study
A study testing Gore Flow Reversal System and Gore Embolic Filter in people with Carotid Stenosis and Constriction, Pathologic, run by W.L.Gore & Associates at 39 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases
- What is being tested?
- Gore Flow Reversal System and Gore Embolic Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,397 participants
- Where
- 39 sitesUnited States
- Study dates
- Apr 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Appleton Medical Cetner
Appleton, Wisconsin, 54911
Emory University
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Heritage Valley Health Network
Beaver, Pennsylvania, 15009
Beth Israel Decaoness Medical Center
Boston, Massachusetts, 02215
Mercy Hospital
Buffalo, New York, 14220
Cooper University Hospital
Camden, New Jersey, 08103
Spirit Physician Services / Capital Cardiovascular Assoc
Camp Hill, Pennsylvania, 17011
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Riverside Methodist Hospital
Columbus, Ohio, 43214
Harper Hospital
Detroit, Michigan, 48201
St John's Medical Center
Detroit, Michigan, 48236
W.L. Gore and Associates, Inc
Flagstaff, Arizona, 86001
Kaiser FOundation Hospitals
Honolulu, Hawaii, 96819
St Luke's Episcopal
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Wisconsin
Madison, Wisconsin, 53792
Southwest General Health Center
Middleburg Heights, Ohio, 44130
St Lukes Medical Center
Milwaukee, Wisconsin, 53215
Heart Care Research Foundation
Mokena, Illinois, 60488
Ochsner Clinic
New Orleans, Louisiana, 70121
Mt Sinai Hospital
New York, New York, 10029
Hoag Memorial Hospital
Newport Beach, California, 92663
Drexel University
Philadelphia, Pennsylvania, 19102
St Joseph Mercy Hospital
Pontiac, Michigan, 48341
Wake Heart Research
Raleigh, North Carolina, 26610
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Rockford Cardiovascular Associates
Rockford, Illinois, 61107
St Francis Hospital
Roslyn, New York, 11576
Covenant Medical Center
Saginaw, Michigan, 48602
University of California San Francisco
San Francisco, California, 94143
N. Central Heart Hospital
Sioux Falls, South Dakota, 57108
St Anthony's Medical Center
St Louis, Missouri, 63128
St Joesph's Medical Center
St Louis, Missouri, 64114
Forsyth Memorial Hospital
Winston-Salem, North Carolina, 27103
York Hospital
York, Pennsylvania, 17405
About this study
Official title: The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
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.
Read the 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.
- Conditions
- Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
- Being tested
- Gore Flow Reversal System, Gore Embolic Filter
- 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
- Medical subject headings
- Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gore Flow Reversal SystemDevice
Also called Neuro Protection System, GORE Neuro Protection System, Parodi, NPS
Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
Gore Embolic FilterDevice
Also called embolic filter, distal protection
Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
| Study group | Role | What they receive |
|---|---|---|
| GFRS EPD | Other | Carotid artery stenting with Gore Flow Reversal System embolic protection device Receives: Device: Gore Flow Reversal System |
| GEF EPD | Other | Carotid artery stenting with Gore Embolic Filter embolic protection device Receives: Device: Gore Embolic Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events (MAE)
Major Adverse Events include death, stroke and myocardial infarction
Measured: Onset from start of index procedure to 30-day follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,397 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343667
- Sponsor's protocol ID
- FRS 09-05
- Acronym
- FREEDOM
- Status last verified
- Jan 2016
- First submitted
- 25 Apr 2011
- Last updated
- 19 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
- ClinicalTrials.gov ID
- NCT01343667
- Acronym / sponsor ID
- FREEDOM / FRS 09-05
- Conditions
- Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
- Keywords
- GORE Neuro Protection System, GORE Flow Reversal System, carotid artery stenosis, embolic protection device, reverse flow, proximal occlusion device, GNPS, Parodi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,397 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Posted 19 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GFRS EPD | Other | Device: Gore Flow Reversal SystemCarotid artery stenting with Gore Flow Reversal System embolic protection device |
| GEF EPD | Other | Device: Gore Embolic FilterCarotid artery stenting with Gore Embolic Filter embolic protection device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gore Flow Reversal SystemAlso: Neuro Protection System, GORE Neuro Protection System, Parodi, NPSEmbolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting | Device | GFRS EPD |
| Gore Embolic FilterAlso: embolic filter, distal protectionEmbolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting | Device | GEF EPD |
Primary outcome
Major Adverse Events (MAE)
Time frame: Onset from start of index procedure to 30-day follow-up assessment
Major Adverse Events include death, stroke and myocardial infarction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gore Flow Reversal System and Gore Embolic Filter in people with Carotid Stenosis and Constriction, Pathologic, run by W.L.Gore & Associates at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (MAE) (time frame: Onset from start of index procedure to 30-day follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.