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

Pulmonary Embolism Clinical Trial

— EVEREST  

Official title:

The Bard® Recovery® Filter Registry (EVEREST) for Patients Who Are Candidates for an Optional (Retrievable) Inferior Vena Cava Filter That Undergo Placement of the Bard® Recovery® Filter.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556426
• Other study ID #: BPV-RC-1332
• Status: Completed
• Phase: N/A
• First received: November 8, 2007
• Last updated: May 25, 2012
• Start date: December 2005
• Est. completion date: April 2007

Study information

• Verified date: May 2012
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolic Disease

Intervention

Device:
• Bard Recovery G2 Filter System
Retrieval of previously placed RECOVERY G2 IVC filter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success (Retrieval)	Technical success for retrieval of the filter such that the entire filter is removed.	1 month post filter retrieval or through 6 months following implantation	No
Primary	Clinical Success (Retrieval)	technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.	Time of Retrieval or through 6 months of implantation	Yes
Primary	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	30 days post retrieval	Yes
Secondary	Filter Migration > 2cm	Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.	30 days post retrieval or 6 months following filter placement	Yes
Secondary	Incidence of Filter Fracture	occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)	at 6 months or at retrieval of the filter	Yes