Comparison Between Two Optional IVC Filters Regardind Ease of Use,Complications and Outcome

Sheba Medical Center

Status: Unknown

Conditions: Trauma; Deep Vein Thrombosis

Treatments: Device: Gunter-Tulip IVC filters; Device: Optease IVC filters

Study type: Interventional

Funder types: Other

Identifiers

NCT00588757

SHEBA-07-4741-UR-CTIL

Details and patient eligibility

About

OptEase filters are easier to retrieve but the dwell time is shorter than the Gunter filters. There are more thrombi on the OptEase than on the Gunter at the time of retrieval. OptEase filter has a better infitration capabillity due to its diamond shape. OptEase filters will hjave more IVC occlusions as a complication.

Full description

We will isert the two filters blindly. We will follow the patients clinically and if needed we will add imaging exams. We will try to retrieve most filters.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients referred for filter insertion

Exclusion criteria

• Young age (<18 years)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

1

Active Comparator group

Description:

Optease filter

Treatment:

Device: Optease IVC filters

2

Active Comparator group

Description:

Tulip filter

Treatment:

Device: Gunter-Tulip IVC filters