Prospective Randomized Evaluation of the Denali and Option Inferior Vena Cava Filters
Phase: NA
Conditions: Venous Thromboembolism
Sponsor: University of California, San Francisco

Prospective Randomized Evaluation of the Denali and Option Inferior Vena Cava Filters 
ODEN Trial: Option vs. Denali IVC Filters  
Principal Investigator 
Maureen P. Kohi, MD 
Associate Professor of Clinical Radiology 
Department of Radiology and Biomedical Imaging 
Division of Vascular and Interventional Radiology 
University of California, San Francisco 
505 Parnassus Avenue, M-361 
San Francisco, CA 94143 
IRB Application/Protocol Version 1.0 April 14, 2014 
IRB Application/Protocol Version 1.1 April 22, 2014 
IRB Approved Application/Protocol Version 1.2 May 23, 2014 
IRB Approved Application/Protocol Version: 1.3 September 24, 2014 
IRB Approved Application/Protocol Version 1.4: March 23, 2015 
UCSF IRB: 14-13307
NCT02201277 
1 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
2 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
3 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
4 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
5 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
6 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
7 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
8 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

/K8K@JK@:JN@CC9<:FDG@C<;8E;8E8CPJ@JN@CC9<G<I=FID<;9PJK8K@JK@:@8ELJ@E>/,//JF=KN8I<

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UCSF IRB: 14-13307
NCT02201277 
9 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
10 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
11 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD


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UCSF IRB: 14-13307
NCT02201277 
12 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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

UCSF IRB: 14-13307
NCT02201277 
13 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

/K8MIFGFLCFJ/3 @OFE.#LIB<0<K8C!D9<;;<;@E=<I@FIM<E8:8M8=@CK<II<DFM8CLJ<F=
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UCSF IRB: 14-13307
NCT02201277 
14 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD


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UCSF IRB: 14-13307
NCT02201277 
15 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
16 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
17 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
18 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD


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UCSF IRB: 14-13307
NCT02201277 
19 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD


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UCSF IRB: 14-13307
NCT02201277 
20 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
21 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
22 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
23 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
24 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
25 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
26 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
27 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
28 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
29 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
30 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

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UCSF IRB: 14-13307
NCT02201277 
31 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD

Human Research Protection Program 
Committee on Human Research 
Notification of Expedited Review Approval
Principal Investigator
Co-Principal Investigator
Maureen P Kohi 
Type of Submission: 
Modification Form
Study Title:
Prospective Randomized Evaluation of the Denali and Option Inferior Vena Cava 
Filters 
IRB #:
14-13307 
Reference #: 
133668 
Committee of Record: 
San Francisco General Hospital Panel 
Study Risk Assignment: Greater than minimal 
Approval Date: 
03/23/2015
Expiration Date: 
All changes to a study must receive CHR approval before they are implemented. Follow the modification 
request instructions. The only exception to the requirement for prior CHR review and approval is when the 
changes are necessary to eliminate apparent immediate hazards to the subject (45 CFR 46.103.b.4, 21 CFR 
56.108.a). In such cases, report the actions taken by following these instructions.   
Expiration Notice: The iRIS system will generate an email notification eight weeks prior to the expiration of this 
study’s approval.  However, it is your responsibility to ensure that an application for continuing review approval 
has been submitted by the required time. In addition, you are required to submit a study closeout report at the 
completion of the project. 
Approved Documents: To obtain a list of documents that were approved with this submission, follow these 
steps: Go to My Studies and open the study – Click on Submissions History – Go to Completed Submissions –
Locate this submission and click on the Details button to view a list of submitted documents and their outcomes. 
For a list of all currently approved documents, follow these steps: Go to My Studies and open the study – Click 
on Informed Consent to obtain a list of approved consent documents and Other Study Documents for a list of 
other approved documents.  
San Francisco Veterans Affairs Medical Center (SFVAMC): If the SFVAMC is engaged in this research, you 
must secure approval of the VA Research & Development Committee in addition to CHR approval and follow all 
applicable VA and other federal requirements. The CHR website has more information. 
UCSF IRB: 14-13307
NCT02201277 
32 of 32
ODEN Trial
Protocol V 1.4 - 23 March 2015
PI Maureen Kohi MD