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

NCT ID: NCT00588757

Last Updated: 2008-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trauma Deep Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Optease filter

Group Type ACTIVE_COMPARATOR

Optease IVC filters

Intervention Type DEVICE

IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.

2

Tulip filter

Group Type ACTIVE_COMPARATOR

Gunter-Tulip IVC filters

Intervention Type DEVICE

IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.

Interventions

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Optease IVC filters

IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.

Intervention Type DEVICE

Gunter-Tulip IVC filters

IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients referred for filter insertion

Exclusion Criteria

* Young age (\<18 years)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sehba Medical Center

Principal Investigators

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Uri Rimon, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba medical center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Central Contacts

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Uri Rimon, MD

Role: CONTACT

[email protected]
97235302673

Facility Contacts

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Uri Rimon, MD

Role: primary

[email protected]
97235302673

Other Identifiers

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SHEBA-07-4741-UR-CTIL

Identifier Type: -

Identifier Source: org_study_id

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