Status:
COMPLETED
Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)
Lead Sponsor:
Cordis US Corp.
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter
Eligibility Criteria
Inclusion
- · 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
- · 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00233740
Start Date
September 1 2003
End Date
May 1 2005
Last Update
August 5 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.