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Completed

NCT Number: NCT00233740

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

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

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPTEASE Vena Cava Filter

Device

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. To assess significant tilting (> 15° off the axis of the IVC) up to 6-month follow-up.

  6. To assess filter fracture up to 6-month follow-up.

  7. Procedure-related bleeding (defined as requiring transfusion or > 3 gm decrease in hemoglobin).

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Oct 6, 2005
Registry last updated
Aug 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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