Cook IVC Filter Study (CIVC)

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Günther Tulip® Vena Cava Filter; Device: Cook Celect® Vena Cava Filters

• Study Type: Interventional
• Enrollment (Actual): 473
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital
  • Hull, United Kingdom, HU3 2JZ
    • Hull Royal Infirmary
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
  • Hampshire
    • Southampton, Hampshire, United Kingdom, S016 6YD
      • Southampton General Hospital
  • Meyerside
    • Liverpool, Meyerside, United Kingdom, L7 8XP
      • The Royal Liverpool University Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85021
      • Abrazo Arrowhead Campus
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Health - Shands
    • Miami, Florida, United States, 33176
      • Miami Cardiac and Vascular Institute
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular and Interventional
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Peoria, Illinois, United States, 61637
      • OSF St. Francis/Peoria Radiology Research and Education Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • North Carolina Memorial Hospital
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital - Smith Tower
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Cook Celect® Vena Cava Filters; Temporary or permanent filter placement for the prevention of pulmonary embolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Filter Retrieval Rate	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)	2 years

Collaborators and Investigators

• Sponsor: Cook Research Incorporated
• Investigators: 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 record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 18, 2018
• Study Completion (Actual): August 9, 2019

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Venous thrombosis; venous thromboembolism; pulmonary embolism; vena cava, inferior; vena cava filters
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 12-018 (CTSU)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes