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

Not Applicable

• Conditions: Trauma; Deep Vein Thrombosis
• Interventions: Device: Optease IVC filters; Device: Gunter-Tulip IVC filters

• Registration Number: NCT00588757
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2007-12
• Study First Submitted: 2007-12-25
• Study First Submitted QC: 2008-01-08
• Last Update Submitted: 2008-01-08
• Study First Posted: 2008-01-09
• Last Update Posted: 2008-01-09
• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2009-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients referred for filter insertion

Exclusion Criteria

• Young age (<18 years)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Optease IVC filters	Optease filter
2	Gunter-Tulip IVC filters	Tulip filter

Primary Outcome Measures

Name	Time	Method
comparing the two filters	1 year

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Tel hashomer, Israel