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

This study is not yet open for participant recruitment.

Verified by Sheba Medical Center, December 2007

First Received: December 25, 2007 Last Updated: January 8, 2008 History of Changes

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00588757

Purpose

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.

Condition	Intervention
Trauma Deep Vein Thrombosis	Device: Optease IVC filters Device: Gunter-Tulip IVC filters

MedlinePlus related topics: Deep Vein Thrombosis Injuries Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prospective Comparison Between OptEase and Gunter-Tulip

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

comparing the two filters [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Optease filter	Device: Optease IVC filters IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
2: Active Comparator Tulip filter	Device: Gunter-Tulip IVC filters IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients referred for filter insertion

Exclusion Criteria:

Young age (<18 years)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588757

Contacts

Contact: Uri Rimon, MD

97235302673

rimonu@sheba.health.gov.il

Locations

Israel
Sheba medical center
Tel hashomer, Israel, 52621

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:

Uri Rimon, MD

Sheba Medical Center

More Information

No publications provided

Responsible Party:	Sehba Medical Center ( Dr. Uri Rimon )
Study ID Numbers:	SHEBA-07-4741-UR-CTIL
Study First Received:	December 25, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00588757 History of Changes
Health Authority:	Israel: Ethics Commission

Keywords provided by Sheba Medical Center:

IVC filters
Trauma
Dwell time

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases

Wounds and Injuries
Venous Thrombosis
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on May 07, 2009