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Cook IVC Filter Study (CIVC)

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ClinicalTrials.gov Identifier: NCT02046096
Recruitment Status : Active, not recruiting
First Posted : January 27, 2014
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Brief Summary:
This prospective, multicenter, single-arm clinical study will further evaluate the safety and effectiveness of Cook's permanent and retrievable 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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Device: Günther Tulip® Vena Cava Filter Device: Cook Celect® Vena Cava Filter 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
Estimated Study Completion Date : January 2020

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




Primary Outcome Measures :
  1. Technical placement success and freedom from new symptomatic PE while a filter is indwelling. [ Time Frame: 12 months ]
  2. Freedom from major adverse events. [ Time Frame: 12 months ]


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
  • Allergy or sensitivity to device materials or contrast medium
  • Pregnant or planning to become pregnant in the next 12 months
  • Patient refuses blood transfusions
  • At risk of septic embolism
  • Life expectancy less than 12 months
  • 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


  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

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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT02046096     History of Changes
Other Study ID Numbers: 12-018
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
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