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

This study has been completed.
Information provided by:
Cordis Corporation Identifier:
First received: October 4, 2005
Last updated: August 4, 2008
Last verified: August 2008
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: 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00233740

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

Publications: Identifier: NCT00233740     History of Changes
Other Study ID Numbers: P02-7001
Study First Received: October 4, 2005
Last Updated: August 4, 2008

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases processed this record on May 25, 2017