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

NCT00556426 | Completed Results DMC

• 1 other identifier: BPV-RC-1332
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Embolism; Venous Thromboembolic Disease

Keywords

Venous Thromboembolic Disease; IVC Filter; Pulmonary Embolism

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Filter Migration > 2cm

  30 days post retrieval or 6 months following filter placement

• Incidence of Filter Fracture

  at 6 months or at retrieval of the filter

Study Arms (1)

Filter

EXPERIMENTAL

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

Device: Bard Recovery G2 Filter System

Interventions

Bard Recovery G2 Filter System DEVICE

Retrieval of previously placed RECOVERY G2 IVC filter

Also known as: Bard Recovery G2 Filter

Filter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• C. R. Bard: lead

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: John Reviere, Director of Clinical Affairs
• Organization: C.R. Bard

john.reviere@crbard.com

480-303-2644

Study Officials

• John A Kaufman, MD

  OHSU, Portland, Oregon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 12, 2007
• Study Start: December 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: June 1, 2012
• Results First Posted: May 11, 2011

Record last verified: 2012-05