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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02046096
Registration number
NCT02046096
Ethics application status
Date submitted
23/01/2014
Date registered
27/01/2014
Date last updated
20/01/2022
Titles & IDs
Public title
Cook IVC Filter Study
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Scientific title
Cook IVC Filter Study
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Secondary ID [1]
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12-018
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Universal Trial Number (UTN)
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Trial acronym
CIVC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Günther Tulip® Vena Cava Filter
Treatment: Devices - Cook Celect® Vena Cava Filters
Experimental: Günther Tulip® Vena Cava Filter - Günther Tulip® Vena Cava Filter
Experimental: Cook Celect® Vena Cava Filters - Cook Celect® Vena Cava Filters
Treatment: Devices: Günther Tulip® Vena Cava Filter
Temporary or permanent filter placement for the prevention of pulmonary embolism
Treatment: Devices: Cook Celect® Vena Cava Filters
Temporary or permanent filter placement for the prevention of pulmonary embolism
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.
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Assessment method [1]
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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).
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Timepoint [1]
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12 months
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Primary outcome [2]
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The Rate of 12-month Freedom From Major Adverse Events (MAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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12 months
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Primary outcome [3]
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Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).
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Assessment method [3]
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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.
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Timepoint [3]
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12 months
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Secondary outcome [1]
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Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling
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Assessment method [1]
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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).
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)
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Assessment method [2]
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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.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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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.
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Assessment method [3]
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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.
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Timepoint [3]
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12 months
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Eligibility
Key inclusion criteria
- Requires temporary or permanent IVC filter placement for the prevention of PE
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/08/2019
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Sample size
Target
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Accrual to date
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Final
473
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
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Arizona
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California
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Illinois
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Maryland
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New Hampshire
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New York
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North Carolina
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Virginia
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United Kingdom
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Hampshire
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United Kingdom
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Meyerside
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United Kingdom
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Cambridge
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United Kingdom
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Hull
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United Kingdom
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State/province [18]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Cook Research Incorporated
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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 placement for the prevention of
pulmonary embolism (PE).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02046096
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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H. Bob Smouse, MD
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Address
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OSF St. Francis/Peoria Radiology Research and Education Foundation
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02046096
Download to PDF