Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter. (EVEREST)

C. R. Bard

Status: Completed

Conditions: Pulmonary Embolism; Venous Thromboembolic Disease

Treatments: Device: Bard Recovery G2 Filter System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556426

BPV-RC-1332

Details and patient eligibility

About

This study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in patients with pulmonary thromboembolism.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is at temporary , increased risk of pulmonary embolism requiring caval interruption

Exclusion criteria

• The patient has implanted filter in the IVC or superior vena cava (SVC)
• The patient has a duplicated or left-sided IVC
• The patient has a known untreatable or uncontrollable malignancy
• The patient has severe spinal deformity
• The patient has a creatinine > 2.0 mg/dl
• The patient has a life expectancy of < 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Filter

Experimental group

Description:

All subjects enrolled to the study are in this arm. All subjects receive a filter.

Treatment:

Device: Bard Recovery G2 Filter System