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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

April 25, 2011
January 14, 2014
April 2011
November 2013   (final data collection date for primary outcome measure)
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 ]
Evaluate the Major Adverse Event(MAE) rate with the commercial GORE Flow Reversal System through comparison with a performance goal MAE rate based on results from the Gore EMPiRE Clinical Study [ Time Frame: Treatment through 30 day visit window ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01343667 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
The GORE FREEDOM Study
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
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 Flow Reversal System
    Intervention: Procedure: Embolic Protection during carotid artery angioplasty and stenting
  • Carotid Artery Stenting with the GORE Embolic Filter
    Intervention: Procedure: Embolic Protection during carotid artery angioplasty and stenting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1398
January 2014
November 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01343667
FRS 09-05
No
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Not Provided
W.L.Gore & Associates
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP