Trial Outcomes & Findings for RexMedical- Option* Vena Cava Filter IDE Study (NCT NCT00488865)

Results Overview

Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

up to 180 days

Results posted on

2010-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Option IVC Filter Device Placement All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RexMedical- Option* Vena Cava Filter IDE Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Option IVC Filter Device Placement n=100 Participants All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
Age, Customized <18 years	0 participants n=5 Participants
Age, Customized >=18 years	100 participants n=5 Participants
Age Continuous	59.1 years STANDARD_DEVIATION 16.7 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 180 days

Population: The number of participants was determined per intention to treat (ITT).

Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.

Outcome measures

Outcome measures
Measure	Option IVC Filter Device Placement n=100 Participants All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
Percentage of Participants With Clinical Success	88 Percent of Participants Interval 81.0 to 100.0

PRIMARY outcome

Timeframe: upto 175 days

Population: The population for Option filter retrieval was based on intention to treat (ITT). Retrieval procedures were attempted in 39 of the 100 enrolled patients.

Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.

Outcome measures

Outcome measures
Measure	Option IVC Filter Device Placement n=39 Participants All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
Percentage of Participants With Retrieval Clinical Success	92 Percent of Participants Interval 81.0 to 100.0

SECONDARY outcome

Timeframe: Immediately post placement procedure

Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism.

Outcome measures

Outcome measures
Measure	Option IVC Filter Device Placement n=100 Participants All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
Placement Technical Success	100 Percent of Participants Interval 100.0 to 100.0

Adverse Events

Option IVC Filter Device Placement

Serious events: 65 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Option IVC Filter Device Placement n=100 participants at risk All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
General disorders Device/Procedure Related SAE	13.0% 13/100 • Number of events 17
General disorders Non Device/Procedure Related SAE	62.0% 62/100 • Number of events 216

Other adverse events

Other adverse events
Measure	Option IVC Filter Device Placement n=100 participants at risk All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
General disorders Device/Procedure Related AE	16.0% 16/100 • Number of events 20
General disorders Non Device/Procedure Related AE	73.0% 73/100 • Number of events 338

Additional Information

James Bressler

Rex Medical

Phone: 610-940-0665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place