Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)

Study Overview
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Brief Summary
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The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter

Official Title
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The Cordis Protection From Pulmonary Embolism With the Permanent OptEase™ Filter - A Post Marketing Surveillance Study (PROOF Study)

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: OPTEASE Vena Cava Filter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OPTEASE Vena Cava Filter|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  |  |