Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)
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|ClinicalTrials.gov Identifier: NCT00233740|
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : August 5, 2008
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Device: OPTEASE Vena Cava Filter||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Cordis Protection From Pulmonary Embolism With the Permanent OptEase™ Filter - A Post Marketing Surveillance Study (PROOF Study)|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||May 2005|
- The co-primary endpoints are migration of the OptEase™ IVC filter as determined by abdominal x-ray at 1-month post-implantation and symptomatic thrombosis at 1-month post-implantation. Migration is defined as > 2 cm movement in either cranial or caudal
- To assess major adverse event rates related to the filter or filter procedure, up to 6-month follow-up, in aggregate and individually. Major adverse events are defined as 1) death, 2) pulmonary embolism, 3) symptomatic thrombosis, 4) caval penetration
- To assess the longer-term stability of the filter defined by the lack of migration as seen on abdominal x-ray at 6-month post-implantation. Migration is defined as > 2 cm movement in either cranial or caudal direction as seen on abdominal x-ray compar
- To assess the clinical success of the filter up to 6-month follow-up. Clinical success is defined as the absence of symptomatic pulmonary embolism (PE) evaluated clinically at post-implantation, 1- and 6-months post-implantation.
- To assess the technical success of the filter up to 6-month follow-up. Technical success is defined as the filter successfully deployed at the intended site in the IVC with the correct orientation.
- To assess significant tilting (> 15° off the axis of the IVC) up to 6-month follow-up.
- To assess filter fracture up to 6-month follow-up.
- Procedure-related bleeding (defined as requiring transfusion or > 3 gm decrease in hemoglobin).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233740
|Principal Investigator:||Peter Weidenfeld, MD||Sunrise Hospital and Medical Center|