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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01343667
First received: April 25, 2011
Last updated: January 22, 2016
Last verified: January 2016
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Major Adverse Events (MAE) [ Time Frame: Onset from start of index procedure to 30-day follow-up assessment ] [ Designated as safety issue: Yes ]
    Major Adverse Events include death, stroke and myocardial infarction


Enrollment: 1397
Study Start Date: April 2011
Study Completion Date: January 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343667

  Show 39 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates
  More Information

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01343667     History of Changes
Other Study ID Numbers: FRS 09-05 
Study First Received: April 25, 2011
Results First Received: December 15, 2015
Last Updated: January 22, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 22, 2016