Trial Outcomes & Findings for ODEN Trial: Option vs. Denali IVC Filters (NCT NCT02201277)

NCT ID: NCT02201277

Last Updated: 2019-09-12

Results Overview

Using imaging analysis, patients will resume their standard care as normal but be encouraged to come back in 30 days for imaging followup and removal. other than that we will look at all available CT and xray imaging that clearly shows the filter and IVC vessel walls. We will count how many participants have penetration of the IVC greater than 3mm and the number of days since placement at imaging timepoints. The number of struts or hooks per filter with penetration will also be recorded.

Recruitment status

TERMINATED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

in dwelling time in 1 day after filter insertion up to 3 years.

Results posted on

2019-09-12

Participant Flow

From April 2014-May 2016, patients coming to University of California, San Francisco Interventional Radiology (IR) with a MD referral for an Inferior Vena Cava (IVC) filter were invited to join a study of two FDA approved filters. After informed consent, subjects were randomized 1:1 to receive either a Denali or Option Elite filter.

Unit of analysis: retrievable vena cava filters

Participant milestones

Participant milestones
Measure	Denali Denali brand IVC Filter will be placed in patients randomized to Denali Arm.	Option Elite Option Elite brand IVC Filter will be placed in patients randomized to Option Arm.
Overall Study STARTED	24 25	21 20
Overall Study Filter Retrieval	17 17	16 16
Overall Study Signed ICF But Did Not Enroll	0 0	1 1
Overall Study Filter Ruled to be Permanent	2 2	2 2
Overall Study Lost to Follow up	2 2	1 1
Overall Study Death (Before Removal)	3 3	4 4
Overall Study Complicated Retrieval	2 2	0 0
Overall Study Failed Retrieval (Referred Elsewhere)	1 1	0 0
Overall Study COMPLETED	17 18	16 16
Overall Study NOT COMPLETED	7 7	5 4

Reasons for withdrawal

Reasons for withdrawal
Measure	Denali Denali brand IVC Filter will be placed in patients randomized to Denali Arm.	Option Elite Option Elite brand IVC Filter will be placed in patients randomized to Option Arm.
Overall Study Death	3	4
Overall Study Lost to Follow-up	2	1
Overall Study Failed retrieval	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

ODEN Trial: Option vs. Denali IVC Filters

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Denali n=25 filters Denali brand IVC Filter will be placed in patients randomized to Denali Arm.	Option n=20 filters Option Elite IVC Filter brand IVC Filter will be placed in patients randomized to Option Arm.	Total n=45 filters Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants	12 Participants n=107 Participants	24 Participants n=206 Participants
Age, Categorical >=65 years	12 Participants n=99 Participants	9 Participants n=107 Participants	21 Participants n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	10 Participants n=107 Participants	21 Participants n=206 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	11 Participants n=107 Participants	24 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment United States	24 participants n=99 Participants	21 participants n=107 Participants	45 participants n=206 Participants
Race (NIH/OMB) White	17 Participants n=99 Participants	16 Participants n=107 Participants	33 Participants n=206 Participants
Race (NIH/OMB) More than one race	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Indication for filter placement VTE and contraindication to anticoagulation	13 Participants n=99 Participants	11 Participants n=107 Participants	24 Participants n=206 Participants
Indication for filter placement Prophylactic (no current thromboembolic disease)	8 Participants n=99 Participants	8 Participants n=107 Participants	16 Participants n=206 Participants
Indication for filter placement Failure to maintain anti coagulation	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Indication for filter placement Recurrent Pulmonary Embolism Despite Therapy	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Indication for filter placement Complication from Anti coagulation	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Filter Indwelling Time	378.7 days since filter placement n=25 filters	277.1 days since filter placement n=20 filters	331.3 days since filter placement n=45 filters

PRIMARY outcome

Timeframe: in dwelling time in 1 day after filter insertion up to 3 years.

Population: patients consented to the trial and needing a temporary ivc filter

Outcome measures

Outcome measures
Measure	Denali n=24 Participants Denali filter randomized participants	Option n=20 Participants Option filter randomized participants
IVC: Filter Penetration	24 Participants	20 Participants

SECONDARY outcome

Timeframe: 0-1733 days

Population: Imaging was analyzed to see if filter penetration could be observed and there was some penetration on imaging but nothing beyond 3mm.

All CT studies with IVC penetration ≥ 3 mm, (%)

Outcome measures

Outcome measures
Measure	Denali n=24 Participants Denali filter randomized participants	Option n=20 Participants Option filter randomized participants
Computerized Tomography (CT) Studies With IVC Penetration	0 Penetrating filter struts	0 Penetrating filter struts

SECONDARY outcome

Timeframe: 30 days

The number of participants with IVC filter migration in terms of distance migrated from initial placement location 30 days after filter placement will be assessed radiographically.

Outcome measures

Outcome measures
Measure	Denali n=24 Participants Denali filter randomized participants	Option n=20 Participants Option filter randomized participants
Number of Participants With IVC Filter Migration	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0-365 days post placement until project closure or patient endpoint reached

number of participants with tilt of greater than 15 degrees in any CT imaging studies after filter placement and before removal of filter or study endpoint reached.

Outcome measures

Outcome measures
Measure	Denali n=24 Participants Denali filter randomized participants	Option n=20 Participants Option filter randomized participants
IVC Filter Tilt	0 participants	0 participants

SECONDARY outcome

Timeframe: 30 days

Fracture of the component legs and struts of the IVC filter will be determined radiographically 30 days after placement.

Outcome measures

Outcome measures
Measure	Denali n=24 Participants Denali filter randomized participants	Option n=20 Participants Option filter randomized participants
IVC Filter Fracture	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: the population sample size was not large enough to see differences between groups.

Thrombus (or clot) formed in the IVC filter 30 days after placement will be assessed radiographically.

Outcome measures

Outcome measures
Measure	Denali n=24 Participants Denali filter randomized participants	Option n=20 Participants Option filter randomized participants
IVC Filter Clot	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Number of participants who had filters removed after 30 days up to 1 year

The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.

Outcome measures

Outcome measures
Measure	Denali n=24 Filter Denali filter randomized participants	Option n=20 Filter Option filter randomized participants
IVC Filter Improved Patient Follow Up and Prompt Filter Removal	17 Filter	16 Filter

SECONDARY outcome

Timeframe: Number of participants who had filters removed after 30 days up to 1 year

Population: Participants

Outcome measures

Outcome measures
Measure	Denali n=24 Filter Denali filter randomized participants	Option n=20 Filter Option filter randomized participants
IVC Filter Improved Patient Follow Up and Prompt Filter Removal: Number of Days	161.7 Days	130.8 Days

Adverse Events

Denali

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Option

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Denali n=24 participants at risk Denali brand IVC Filter will be placed in patients randomized to Denali Arm. 24 enrolled	Option n=20 participants at risk Option brand IVC Filter will be placed in patients randomized to Option Arm. 22 enrolled 1 withdrawn by investigator after consent before randomization and 1 patient had 2 filters placed.
Vascular disorders Filters with IVC penetration ≥ 3 mm	0.00% 0/24 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.	0.00% 0/20 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.
Vascular disorders All CTs with IVC penetration	0.00% 0/24 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.	0.00% 0/20 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.
Vascular disorders Filter Fracture	0.00% 0/24 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.	0.00% 0/20 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.
Vascular disorders Filter movement	0.00% 0/24 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.	0.00% 0/20 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.
Vascular disorders Filter Tilt > or = 15 deg.	0.00% 0/24 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.	0.00% 0/20 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.
Vascular disorders All CT studies with Tilt	0.00% 0/24 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.	0.00% 0/20 • During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal. All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as: * stable * new therapy started * patient lost to follow-up * withdraws * death All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome \& resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.

Other adverse events

Adverse event data not reported

Additional Information

Maureen Kohi, MD

University of California, San Francisco, Interventional Radiology

Phone: (415) 353-1300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place