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

August 4, 2008 updated by: Cordis Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cordis Corporation

Investigators

  • Principal Investigator: Peter Weidenfeld, MD, Sunrise Hospital and Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (Estimate)

October 6, 2005

Study Record Updates

Last Update Posted (Estimate)

August 5, 2008

Last Update Submitted That Met QC Criteria

August 4, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02-7001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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