Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF) - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00233740

Purpose

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

Condition	Intervention	Phase
Pulmonary Embolism	Device: OPTEASE Vena Cava Filter	Phase IV

MedlinePlus related topics: Pulmonary Embolism X-Rays

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Cordis Protection From Pulmonary Embolism With the Permanent OptEase™ Filter - A Post Marketing Surveillance Study (PROOF Study)

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

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:

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).

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233740

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:

Peter Weidenfeld, MD

Sunrise Hospital and Medical Center

More Information

Publications of Results:

Study ID Numbers:	P02-7001
Study First Received:	October 4, 2005
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00233740
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism

Lung Diseases
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009