The GORE FREEDOM Study

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 14, 2014
Last verified: January 2014
  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
Procedure: Embolic Protection during carotid artery angioplasty and stenting

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group 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:
  • Evaluate the Major Adverse Event(MAE) rate with the commercial GORE Flow Reversal System and GORE Embolic FIlter through comparison with a performance goal MAE rate based on results from the Gore EMPiRE Clinical Study and the Gore EMBOLDEN Clinical Study [ Time Frame: Treatment through 30 day visit window ] [ Designated as safety issue: Yes ]

Enrollment: 1398
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
Carotid Artery Stenting with the GORE Flow Reversal System Procedure: Embolic Protection during carotid artery angioplasty and stenting
Embolic protection by the GORE Flow Reversal System or the GORE Embolic Filter during carotid artery angioplasty and stenting
Other Names:
  • Neuro Protection System
  • GORE Neuro Protection System
  • Parodi
  • NPS
  • FRS
  • PAES
  • proximal protection
  • embolic filter
Carotid Artery Stenting with the GORE Embolic Filter Procedure: Embolic Protection during carotid artery angioplasty and stenting
Embolic protection by the GORE Flow Reversal System or the GORE Embolic Filter during carotid artery angioplasty and stenting
Other Names:
  • Neuro Protection System
  • GORE Neuro Protection System
  • Parodi
  • NPS
  • FRS
  • PAES
  • proximal protection
  • embolic filter

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

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

No publications provided

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
Last Updated: January 14, 2014
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:
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Carotid Stenosis
Central Nervous System Diseases
Cerebrovascular Disorders
Constriction, Pathologic
Nervous System Diseases
Vascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014