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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

April 25, 2011
January 22, 2016
April 2011
November 2013   (final data collection date for primary outcome measure)
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
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
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GORE Flow Reversal System and GORE Embolic Filter Extension 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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
  • 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
  • Device: Gore Embolic Filter
    Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
    Other Names:
    • embolic filter
    • distal protection
  • GFRS EPD
    Carotid artery stenting with Gore Flow Reversal System embolic protection device
    Intervention: Device: Gore Flow Reversal System
  • GEF EPD
    Carotid artery stenting with Gore Embolic Filter embolic protection device
    Intervention: Device: Gore Embolic Filter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1397
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01343667
FRS 09-05
No
Not Provided
Not Provided
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Not Provided
W.L.Gore & Associates
January 2016

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