Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)
|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)|
|Estimated 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|
|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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233740
|Principal Investigator:||Peter Weidenfeld, MD||Sunrise Hospital and Medical Center|