Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)
This study has been completed.
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First received: October 4, 2005
Last updated: August 4, 2008
Last verified: August 2008
The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Cordis Protection From Pulmonary Embolism With the Permanent OptEase™ Filter - A Post Marketing Surveillance Study (PROOF Study)|
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Further study details as provided by Cordis Corporation:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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).
|Study Start Date:||September 2003|
|Study Completion Date:||May 2005|
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