Pulmonary EmbolismCIVCNCT02046096

Cook IVC Filter Study

A study testing Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters in people with Pulmonary Embolism, run by Cook Research Incorporated at 28 sites in 3 countries.

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 prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Embolism
What is being tested?: Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 473 participants
Where: 28 sitesin 3 countries
Study dates: Jan 2014to 9 Aug 2019
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

Requires temporary or permanent IVC filter placement for the prevention of PE

Who cannot join

Less than 18 years of age
Known hypersensitivity or contraindication to contrast medium that cannot be adequately premedicated
Known allergy or sensitivity to cobalt, chromium, or nickel
Pregnant or planning to become pregnant in the next 12 months
Patient refuses blood transfusions
At risk of septic embolism

Show all 11Show fewer

Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
Existing IVC filter
Duplicate IVC
Anatomy that would prevent safe filter placement (e.g., condition of access vessels)
IVC diameter > 30 mm or < 15 mm

Trial locations and contacts

28 sites in 3 countries.

Country

City, postcode or hospital

28 sites in 3 countries

United States22 sites

Johns Hopkins University
Baltimore, Maryland, 21218
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
North Carolina Memorial Hospital
Chapel Hill, North Carolina, 27599
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia Medical Center
Charlottesville, Virginia, 22904
University of Chicago
Chicago, Illinois, 60637
University of Florida Health - Shands
Gainesville, Florida, 32610
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
The Methodist Hospital - Smith Tower
Houston, Texas, 77030
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Miami Cardiac and Vascular Institute
Miami, Florida, 33176
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Coastal Vascular and Interventional
Pensacola, Florida, 32504
OSF St. Francis/Peoria Radiology Research and Education Foundation
Peoria, Illinois, 61637
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Abrazo Arrowhead Campus
Phoenix, Arizona, 85021
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Stony Brook Medicine
Stony Brook, New York, 11794

Other trials in United States

United Kingdom5 sites

Addenbrooke's Hospital
Cambridge, CB2 0QQ
Hull Royal Infirmary
Hull, HU3 2JZ
The Royal Liverpool University Hospital
Liverpool, Meyerside, L7 8XP
John Radcliffe Hospital
Oxford, OX3 9DU
Southampton General Hospital
Southampton, Hampshire, S016 6YD

Other trials in United Kingdom

Australia1 site

The Alfred Hospital
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Conditions: Pulmonary Embolism
Being tested: Günther Tulip® Vena Cava Filter, Cook Celect® Vena Cava Filters
Keywords: Venous thrombosis, pulmonary embolism, vena cava, inferior, vena cava filters, venous thromboembolism
Medical subject headings: Pulmonary Embolism, Venous Thrombosis, Venous Thromboembolism

What participants receive

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

Günther Tulip® Vena Cava FilterDevice
Temporary or permanent filter placement for the prevention of pulmonary embolism
Cook Celect® Vena Cava FiltersDevice
Temporary or permanent filter placement for the prevention of pulmonary embolism

Study groups in NCT02046096
Study group	Role	What they receive
Günther Tulip® Vena Cava Filter	Experimental	Günther Tulip® Vena Cava Filter Receives: Device: Günther Tulip® Vena Cava Filter
Cook Celect® Vena Cava Filters	Experimental	Cook Celect® Vena Cava Filters Receives: Device: Cook Celect® Vena Cava Filters

What is being measured

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

The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.
The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).
Measured: 12 months
The Rate of 12-month Freedom From Major Adverse Events (MAEs)
MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death.
Clinical perforation - Protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ. Documented using CT.
Clinical migration - Caudal or cranial movement of a filter resulting in surgical or endovascular intervention.
Clinical fracture - A loss of structural integrity (breakage or separation) of the filter identified by imaging and associated with clinical sequelae and/or requiring intervention.
Measured: 12 months
Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).
MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death.
A filter retrieval is considered a successful safety result through 12 months, regardless of when the retrieval occurred.
Measured: 12 months

Secondary outcomes (3)

Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling
Rate of technical placement success and 12-month freedom from new symptomatic PE while a filter is indwelling for the combined patient population (i.e., the Celect and Günther Tulip strata).
The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).
Measured: 12 months
Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)
MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death.
Clinical perforation - Protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ. Documented using CT.
Clinical migration - Caudal or cranial movement of a filter resulting in surgical or endovascular intervention.
Clinical fracture - A loss of structural integrity (breakage or separation) of the filter identified by imaging and associated with clinical sequelae and/or requiring intervention.
Measured: 12 months
Number of Participants With Freedom From Grade 2 or Grade 3 Filter Leg Interaction With IVC, Filter Migration, Filter Fracture, and Filter Embolization at 12-month.
Filter interaction with IVC is defined as :
Grade 2: Filter strut is entirely outside of the IVC lumen and within the retroperitoneum as evidenced by a "halo" of retroperitoneal fat around axially viewed strut.
Grade 3: Filter strut is touching, impressing, or perforating another organ (e.g., liver, bowel, aorta, psoas muscle, vertebral body, lymph nodes).
Filter migration : Change in filter position compared to its deployed position (cranial or caudal).
Filter fracture : Any loss of structural integrity (breakage or separation) of the filter identified by imaging or autopsy. Documented by imaging or at autopsy.
Filter embolization : Post-placement movement of the filter or its components to a distant anatomic site completely out of the target zone (i.e., heart/lungs). Documented by imaging or autopsy.
Measured: 12 months

Timeline

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

Jan 20149 Aug 2019

First posted27 Jan 2014 (estimated)
Study startJan 2014
Primary completion18 Dec 2018
Study completion9 Aug 2019

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.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02046096
Sponsor's protocol ID: 12-018
Acronym: CIVC
Status last verified: Jan 2022
First submitted: 23 Jan 2014
Last updated: 20 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated device: 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?

See locations

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All Pulmonary Embolism trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cook IVC Filter Study
ClinicalTrials.gov ID: NCT02046096
Acronym / sponsor ID: CIVC / 12-018
Conditions: Pulmonary Embolism
Keywords: Venous thrombosis, pulmonary embolism, vena cava, inferior, vena cava filters, venous thromboembolism
Study type: Interventional
Recruitment status: Completed
Enrolment: 473 participants (actual)
Lead sponsor: Cook Research IncorporatedIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: 18 Dec 2018 (actual)
Study completion: 9 Aug 2019 (actual)
First posted: 27 Jan 2014 (estimated)
Results: Posted 11 Jan 2022

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Günther Tulip® Vena Cava Filter	Experimental	Device: Günther Tulip® Vena Cava FilterGünther Tulip® Vena Cava Filter
Cook Celect® Vena Cava Filters	Experimental	Device: Cook Celect® Vena Cava FiltersCook Celect® Vena Cava Filters

Who may qualify

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

Key inclusion criteria (1 listed)

Requires temporary or permanent IVC filter placement for the prevention of PE

Key exclusion criteria (11 listed)

Less than 18 years of age
Known hypersensitivity or contraindication to contrast medium that cannot be adequately premedicated
Known allergy or sensitivity to cobalt, chromium, or nickel
Pregnant or planning to become pregnant in the next 12 months
Patient refuses blood transfusions

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
Günther Tulip® Vena Cava FilterTemporary or permanent filter placement for the prevention of pulmonary embolism	Device	Günther Tulip® Vena Cava Filter
Cook Celect® Vena Cava FiltersTemporary or permanent filter placement for the prevention of pulmonary embolism	Device	Cook Celect® Vena Cava Filters

Primary outcome

The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.
Time frame: 12 months
The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).
The Rate of 12-month Freedom From Major Adverse Events (MAEs)
Time frame: 12 months
MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death. Clinical perforation - Protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ. Documented using CT. Clinical migration - Caudal or cranial movement of a filter resulting in surgical or endovascular intervention. Clinical fracture - A loss of structural integrity (breakage or separation) of the filter identified by imaging and associated with clinical sequelae and/or requiring intervention.
Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).
Time frame: 12 months
MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death. A filter retrieval is considered a successful safety result through 12 months, regardless of when the retrieval occurred.

3 secondary outcomes

Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling
Time frame: 12 months
Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)
Time frame: 12 months
Number of Participants With Freedom From Grade 2 or Grade 3 Filter Leg Interaction With IVC, Filter Migration, Filter Fracture, and Filter Embolization at 12-month.
Time frame: 12 months

Results and safety

Results posted to the registry on 11 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Günther Tulip® Vena Cava Filter	149	105
Cook Celect® Vena Cava Filters	324	223

Primary outcome: The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Cook Celect® Vena Cava Filters n = 324
Value	317

Cook Celect® Vena Cava Filters: 12-month rate (%): 97.8 (95% CI 95.6 to 99.1), p <0.0001, One-tailed Exact binomial test

Population analysed: The hypothesis was tested only for patients receiving Celect filters, in accordance with the study protocol.

Primary outcome: The Rate of 12-month Freedom From Major Adverse Events (MAEs)

Time frame: 12 months. Mean (Standard Error). Unit: Rate of Freedom from MAE (%)

Measure	Cook Celect® Vena Cava Filters n = 324
Value	81.5 (4.5)

Cook Celect® Vena Cava Filters: Cumulative probability: 81.5 (95% CI 72.6 to 90.4), p = 0.369, Z-statistic

Population analysed: The CIP defined methodology for analysis of the primary endpoint relied on Kaplan-Meier estimation. However, a large number of patients were censored (n=235), primarily due to filter retrieval (n=204). The hypothesis was tested only for patients receiving Celect filters, in accordance with the study protocol.

Primary outcome: Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Cook Celect® Vena Cava Filters n = 324
Value	281

Cook Celect® Vena Cava Filters: 12-month freedom from MAE rate (%): 86.7 (95% CI 82.5 to 90.2), p = 0.001, One-tailed exact binomial test

Population analysed: The hypothesis was only tested for patients receiving Celect filters, in accordance with the protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cook Celect® Vena Cava Filters	76 of 324 (23.5%)	0 of 324 (0%)	45 of 324
Günther Tulip® Vena Cava Filter	43 of 149 (28.9%)	0 of 149 (0%)	28 of 149

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

H. Bob Smouse, MD principal investigator

OSF St. Francis/Peoria Radiology Research and Education Foundation

Robert Feezor, MD principal investigator

University of Florida Health-Shands

28 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters in people with Pulmonary Embolism, run by Cook Research Incorporated at 28 sites in 3 countries.

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 11 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 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Jan 2022). 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?

The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling. (time frame: 12 months). 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 NCT02046096.

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 20 Jan 2022.