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Trial record 1 of 3 for:    CIVC
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Cook IVC Filter Study (CIVC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046096
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : January 11, 2022
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

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).

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Device: Günther Tulip® Vena Cava Filter Device: Cook Celect® Vena Cava Filters Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cook IVC Filter Study
Study Start Date : January 2014
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : August 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter
Device: Günther Tulip® Vena Cava Filter
Temporary or permanent filter placement for the prevention of pulmonary embolism

Experimental: Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters
Device: Cook Celect® Vena Cava Filters
Temporary or permanent filter placement for the prevention of pulmonary embolism




Primary Outcome Measures :
  1. 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).

  2. 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.


  3. 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.



Secondary Outcome Measures :
  1. Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling [ Time Frame: 12 months ]

    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).


  2. 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 ]

    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.


  3. 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 ]

    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.



Other Outcome Measures:
  1. Filter Retrieval Rate [ Time Frame: 2 years ]

    The filters may be retrieved if clinically indicated. The IVC filter and IVC were assessed on imaging before a retrieval attempt.

    (The filter retrieval rate= the total number of filter retrieved / the total number of filter retrieval attempted)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046096


Locations
Show Show 28 study locations
Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: H. Bob Smouse, MD OSF St. Francis/Peoria Radiology Research and Education Foundation
Principal Investigator: Robert Feezor, MD University of Florida Health-Shands
  Study Documents (Full-Text)

Documents provided by Cook Group Incorporated ( Cook Research Incorporated ):
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT02046096    
Other Study ID Numbers: 12-018
First Posted: January 27, 2014    Key Record Dates
Results First Posted: January 11, 2022
Last Update Posted: January 20, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Venous thrombosis
pulmonary embolism
vena cava, inferior
vena cava filters
venous thromboembolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases