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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233740
• Other study ID #: P02-7001
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2005
• Last updated: August 4, 2008
• Start date: September 2003
• Est. completion date: May 2005

Study information

• Verified date: August 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• OPTEASE Vena Cava Filter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

References & Publications (1)

Ziegler JW, Dietrich GJ, Cohen SA, Sterling K, Duncan J, Samotowka M. PROOF trial: protection from pulmonary embolism with the OptEase filter. J Vasc Interv Radiol. 2008 Aug;19(8):1165-70. doi: 10.1016/j.jvir.2008.04.020. Epub 2008 Jun 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	To assess significant tilting (> 15° off the axis of the IVC) up to 6-month follow-up.
Secondary	To assess filter fracture up to 6-month follow-up.
Secondary	Procedure-related bleeding (defined as requiring transfusion or > 3 gm decrease in hemoglobin).