Back to resultsProtection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)
Primary Purpose
Pulmonary Embolism
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
OPTEASE Vena Cava Filter
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Embolism
Eligibility Criteria
Inclusion Criteria: · Pulmonary thromboembolism when anticoagulants are contraindicated. Failure of anticoagulant therapy in thromboembolic diseases. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced. Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. Exclusion Criteria: · Patients with risk of septic embolism. Patients with uncontrolled infectious disease. Patients with an IVC diameter > 30 mm. Patients contraindicated for procedures under fluoroscopy. Patients with demonstrated hypersensitivity to one or more of the components of the OptEase™ filter
Sites / Locations
Outcomes
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233740
Brief Title
Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)
Official Title
The Cordis Protection From Pulmonary Embolism With the Permanent OptEase™ Filter - A Post Marketing Surveillance Study (PROOF Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
OPTEASE Vena Cava Filter
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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.
Title
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.
Title
To assess significant tilting (> 15° off the axis of the IVC) up to 6-month follow-up.
Title
To assess filter fracture up to 6-month follow-up.
Title
Procedure-related bleeding (defined as requiring transfusion or > 3 gm decrease in hemoglobin).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
· Pulmonary thromboembolism when anticoagulants are contraindicated.
Failure of anticoagulant therapy in thromboembolic diseases.
Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
Exclusion Criteria:
· Patients with risk of septic embolism.
Patients with uncontrolled infectious disease.
Patients with an IVC diameter > 30 mm.
Patients contraindicated for procedures under fluoroscopy.
Patients with demonstrated hypersensitivity to one or more of the components of the OptEase™ filter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Weidenfeld, MD
Organizational Affiliation
Sunrise Hospital and Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18656008
Citation
Ziegler JW, Dietrich GJ, Cohen SA, Sterling K, Duncan J, Samotowka M. PROOF trial: protection from pulmonary embolism with the OptEase filter. J Vasc Interv Radiol. 2008 Aug;19(8):1165-70. doi: 10.1016/j.jvir.2008.04.020. Epub 2008 Jun 27.
Results Reference
result
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Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)
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