Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms
Phase: NA
Conditions: Intracranial Aneurysms
Sponsor: Microvention-Terumo, Inc.

 
 
 
 
 
 
 
 
Pivotal Study of the MicroVention, Inc. Flow Re-Direction Endoluminal Device (FRED) 
Stent System in the Treatment of Intracranial Aneurysms 
 
NCT01801007 
Document Date: November 14, 2016 
 
 
 

CONFIDENTIAL 
 
 
 
PIVOTAL STUDY OF THE MICROVENTION FLOW RE-DIRECTION ENDOLUMINAL 
DEVICE STENT SYSTEM IN THE TREATMENT OF INTRACRANIAL ANEURYSMS 
 
 
CLINICAL PROTOCOL NUMBER CL12001 
REVISION 4.0, NOVEMBER 14, 2016 
 
 
STUDY SPONSOR:  MicroVention, Inc. 
 
 
 
Prepared By: 
 
 
________________________________________ 
_________________ 
Laraine Pangelina 
 
 
 
Date 
Sr. Regulatory Affairs Project Manager 
 
 
________________________________________ 
_________________ 
Krystal Anson 
 
 
 
Date 
Clinical Project Manager 
 
 
Approved By: 
 
 
________________________________________ 
_________________ 
Amy Walters 
 
 
 
Date 
Vice President of Clinical Research 
 
 
________________________________________ 
_________________ 
Irina Kulinets 
 
 
 
Date 
Vice President, Regulatory Affairs & Quality 
Assurance 
 

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