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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00588757
First received: December 25, 2007
Last updated: January 8, 2008
Last verified: December 2007
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Comparison Between OptEase and Gunter-Tulip

Resource links provided by NLM:

U.S. FDA Resources

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
Active Comparator: 1
Optease filter
 Device: Optease IVC filters
IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
Active Comparator: 2
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 Not yet recruiting
Tel hashomer, Israel, 52621
Contact: Uri Rimon, MD     97235302673     rimonu@sheba.health.gov.il    
Principal Investigator: Uri Rimon, MD            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Uri Rimon, MD Sheba Medical Center
  More Information

No publications provided

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

Keywords provided by Sheba Medical Center:
IVC filters
Trauma
Dwell time

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2012