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

Cordis

Status and phase: Completed; Phase 4

Conditions: Pulmonary Embolism

Treatments: Device: OPTEASE Vena Cava Filter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00233740

P02-7001

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)