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

C. R. Bard100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Pulmonary Embolism Venous Thromboembolic Disease

Interventions

Bard Recovery G2 Filter SystemDEVICE

Retrieval of previously placed RECOVERY G2 IVC filter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Technical Success (Retrieval)

Technical success for retrieval of the filter such that the entire filter is removed.

Time frame: 1 month post filter retrieval or through 6 months following implantation

Clinical Success (Retrieval)

technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.

Time frame: Time of Retrieval or through 6 months of implantation

Percentage of Participants With Adverse Events Through 30 Days Post Retrieval

Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure

Time frame: 30 days post retrieval

Secondary Outcomes

Filter Migration > 2cm

Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.

Time frame: 30 days post retrieval or 6 months following filter placement

Incidence of Filter Fracture

occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)

Time frame: at 6 months or at retrieval of the filter

Data from ClinicalTrials.gov

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