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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00233740
First Posted: October 6, 2005
Last Update Posted: August 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cordis Corporation
  Purpose
The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter

Condition Intervention Phase
Pulmonary Embolism Device: OPTEASE Vena Cava Filter Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)

Resource links provided by NLM:


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).

Estimated Enrollment: 150
Study Start Date: September 2003
Study Completion Date: May 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233740


Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Peter Weidenfeld, MD Sunrise Hospital and Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00233740     History of Changes
Other Study ID Numbers: P02-7001
First Submitted: October 4, 2005
First Posted: October 6, 2005
Last Update Posted: August 5, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases


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