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

Cordis US Corp.150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Pulmonary Embolism

Interventions

OPTEASE Vena Cava FilterDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.