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FREEDOM

Summary of Trial: 
 
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
Principal Investigator:Mahmoud B Malas, M.D., MHS, FACS
Study Coordinator:

Umair Qazi, M.D., MPH
Email: uqazi1@jhmi.edu

Study Long Title: 

GORE® Flow Reversal System and GORE® Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes

Study Short Title: FREEDOM
JHU IRB Number:

NA_00049841

Funding Source:W.L. Gore & Associates, Inc.
Important Inclusion Criteria:
  1. Patient, or patient’s legal representative, is able and willing to provide informed consent.
  2. Patient must be at least 18 years of age, or older.
  3. Patient will be selected and treated according to the GORE® Flow Reversal System or the GORE® Embolic Filter IFU.
Important Exclusion Criteria:

Patient is contraindicated for the embolic protection device arm they are selected by the investigator to receive: Either
FRS 09-05 PROTOCOL GORE® Flow Reversal System
6.0 Investigator Responsibilities GORE® Embolic Filter
Confidential Information 17
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 cannot be enrolled.

Clinical Trial Site: Johns Hopkins Bayview Medical Center
4940 Eastern Ave
Baltimore MD 21224
Start Date:2012
Anticipated End Date:2017
Compensation for Participating: None











































 

 

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