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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00233740
First received: October 4, 2005
Last updated: August 4, 2008
Last verified: August 2008
  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
Endpoint Classification: Safety/Efficacy Study
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 4, 2005
Last Updated: August 4, 2008
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014