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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Cook IVC Filter Study
Secondary ID [1] 0 0
12-018
Universal Trial Number (UTN)
Trial acronym
CIVC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
The Rate of 12-month Freedom From Major Adverse Events (MAEs)
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
* Requires temporary or permanent IVC filter placement for the prevention of PE
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/08/2019
Sample size
Target
Accrual to date
Final
473
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Rhode Island
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Hampshire
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Meyerside
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Cambridge
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Hull
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cook Research Incorporated
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT02046096
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
H. Bob Smouse, MD
Address 0 0
OSF St. Francis/Peoria Radiology Research and Education Foundation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02046096