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

Phase 4

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT00233740
• Lead Sponsor: Cordis Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study Completion: 2005-05
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-06
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-04
• Last Update Posted: 2008-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).