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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-05-31

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

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OPTEASE Vena Cava Filter

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Peter Weidenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Sunrise Hospital and Medical Center

References

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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.

Reference Type RESULT

PMID: 18656008 (View on PubMed)

Other Identifiers

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P02-7001

Identifier Type: -

Identifier Source: org_study_id