Pulmonary EmbolismEVERESTNCT00556426

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

A study testing Bard Recovery G2 Filter System in people with Pulmonary Embolism and Venous Thromboembolic Disease, run by C. R. Bard.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Embolism, Venous Thromboembolic Disease
What is being tested?: Bard Recovery G2 Filter System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: Dec 2005to Apr 2007
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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.

Conditions: Pulmonary Embolism, Venous Thromboembolic Disease
Being tested: Bard Recovery G2 Filter System
Keywords: Venous Thromboembolic Disease, IVC Filter, Pulmonary Embolism
Medical subject headings: Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bard Recovery G2 Filter SystemDevice
Also called Bard Recovery G2 Filter
Retrieval of previously placed RECOVERY G2 IVC filter

Study groups in NCT00556426
Study group	Role	What they receive
Filter	Experimental	All subjects enrolled to the study are in this arm. All subjects receive a filter. Receives: Device: Bard Recovery G2 Filter System

What is being measured

The primary outcome is the main question the study is designed to answer.

Technical Success (Retrieval)
Technical success for retrieval of the filter such that the entire filter is removed.
Measured: 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.
Measured: 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
Measured: 30 days post retrieval

Secondary outcomes (2)

Filter Migration > 2cm
Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.
Measured: 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)
Measured: at 6 months or at retrieval of the filter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Apr 2007

First posted12 Nov 2007 (estimated)
Study startDec 2005
Primary completionApr 2007
Study completionApr 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
More trials run by C. R. BardThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00556426
Sponsor's protocol ID: BPV-RC-1332
Acronym: EVEREST
Status last verified: May 2012
First submitted: 8 Nov 2007
Last updated: 1 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
RecruitingObservational study
Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
Pulmonary Embolism (Diagnosis)
Active, not recruitingPhase 3
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Pulmonary Embolism
Not yet recruitingPhase 4
Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism
Pulmonary Embolism Acute
Not yet recruitingPhase 2
Phase IIA Study of Belzutifan in EPAS1-, EGLN1-, or VHL-Mutant Erythrocytosis
Erythrocytosis, Pulmonary Hypertension

All Pulmonary Embolism trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00556426
Acronym / sponsor ID: EVEREST / BPV-RC-1332
Conditions: Pulmonary Embolism, Venous Thromboembolic Disease
Keywords: Venous Thromboembolic Disease, IVC Filter, Pulmonary Embolism
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Apr 2007 (actual)
Study completion: Apr 2007 (actual)
First posted: 12 Nov 2007 (estimated)
Results: Posted 11 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Filter	Experimental	Device: Bard Recovery G2 Filter SystemAll subjects enrolled to the study are in this arm. All subjects receive a filter.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bard Recovery G2 Filter SystemAlso: Bard Recovery G2 FilterRetrieval of previously placed RECOVERY G2 IVC filter	Device	Filter

Primary outcome

Technical Success (Retrieval)
Time frame: 1 month post filter retrieval or through 6 months following implantation
Technical success for retrieval of the filter such that the entire filter is removed.
Clinical Success (Retrieval)
Time frame: Time of Retrieval or through 6 months of implantation
technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.
Percentage of Participants With Adverse Events Through 30 Days Post Retrieval
Time frame: 30 days post retrieval
Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure

2 secondary outcomes

Filter Migration > 2cm
Time frame: 30 days post retrieval or 6 months following filter placement
Incidence of Filter Fracture
Time frame: at 6 months or at retrieval of the filter

Results and safety

Results posted to the registry on 11 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients Receiving the Filter	100	91

Primary outcome: Technical Success (Retrieval)

Time frame: 1 month post filter retrieval or through 6 months following implantation. Number. Unit: participants

Measure	All Patients Receiving the Filter n = 61
Value	58

Population analysed: 61 of 100 patients enrolled underwent filter retrieval during the study.

Primary outcome: Clinical Success (Retrieval)

Time frame: Time of Retrieval or through 6 months of implantation. Number. Unit: participants

Measure	All Patients Receiving the Filter n = 61
Value	57

Population analysed: 61/100 patients experienced filter retrieval during the study

Primary outcome: Percentage of Participants With Adverse Events Through 30 Days Post Retrieval

Time frame: 30 days post retrieval. Number (95% Confidence Interval). Unit: percentage of participants

Measure	All Patients Receiving the Filter n = 61
Value	14.8 (7.1 to 26.6)

Population analysed: 61 of 100 patients underwent filter retrieval during the study.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients Receiving the Filter	6 of 100 (6%)	70 of 100 (70%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Embolism

Not yet recruiting
CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
RecruitingObservational study
Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
Pulmonary Embolism (Diagnosis)
Active, not recruitingPhase 3
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Pulmonary Embolism
Not yet recruitingPhase 4
Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism
Pulmonary Embolism Acute
Not yet recruitingPhase 2
Phase IIA Study of Belzutifan in EPAS1-, EGLN1-, or VHL-Mutant Erythrocytosis
Erythrocytosis, Pulmonary Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John A Kaufman, MD principal investigator

OHSU, Portland, Oregon

Questions about this trial

What is this clinical trial studying?

A study testing Bard Recovery G2 Filter System in people with Pulmonary Embolism and Venous Thromboembolic Disease, run by C. R. Bard.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical Success (Retrieval) (time frame: 1 month post filter retrieval or through 6 months following implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00556426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.