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Cook IVC Filter Study (CIVC)

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Günther Tulip® Vena Cava Filter
Cook Celect® Vena Cava Filters
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Venous thrombosis, pulmonary embolism, vena cava, inferior, vena cava filters, venous thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abrazo Arrowhead Campus
  • Cedars-Sinai Medical Center
  • University of Florida Health - Shands
  • Mount Sinai Medical Center
  • Miami Cardiac and Vascular Institute
  • Coastal Vascular and Interventional
  • University of Chicago
  • OSF St. Francis/Peoria Radiology Research and Education Foundation
  • Johns Hopkins University
  • MedStar Union Memorial Hospital
  • Dartmouth Hitchcock Medical Center
  • Stony Brook Medicine
  • North Carolina Memorial Hospital
  • Carolinas Medical Center
  • Oregon Health and Science University
  • Penn State Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center
  • Rhode Island Hospital
  • The Methodist Hospital - Smith Tower
  • University of Texas Health Science Center at San Antonio
  • University of Virginia Medical Center
  • The Alfred Hospital
  • Southampton General Hospital
  • The Royal Liverpool University Hospital
  • Addenbrooke's Hospital
  • Hull Royal Infirmary
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Günther Tulip® Vena Cava Filter

Cook Celect® Vena Cava Filters

Arm Description

Günther Tulip® Vena Cava Filter

Cook Celect® Vena Cava Filters

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
January 23, 2014
Last Updated
January 11, 2022
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02046096
Brief Title
Cook IVC Filter Study
Acronym
CIVC
Official Title
Cook IVC Filter Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
August 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Venous thrombosis, pulmonary embolism, vena cava, inferior, vena cava filters, venous thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
473 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Günther Tulip® Vena Cava Filter
Arm Type
Experimental
Arm Description
Günther Tulip® Vena Cava Filter
Arm Title
Cook Celect® Vena Cava Filters
Arm Type
Experimental
Arm Description
Cook Celect® Vena Cava Filters
Intervention Type
Device
Intervention Name(s)
Günther Tulip® Vena Cava Filter
Intervention Description
Temporary or permanent filter placement for the prevention of pulmonary embolism
Intervention Type
Device
Intervention Name(s)
Cook Celect® Vena Cava Filters
Intervention Description
Temporary or permanent filter placement for the prevention of pulmonary embolism
Primary Outcome Measure Information:
Title
The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.
Description
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).
Time Frame
12 months
Title
The Rate of 12-month Freedom From Major Adverse Events (MAEs)
Description
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.
Time Frame
12 months
Title
Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling
Description
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).
Time Frame
12 months
Title
Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)
Description
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.
Time Frame
12 months
Title
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.
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Filter Retrieval Rate
Description
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)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Bob Smouse, MD
Organizational Affiliation
OSF St. Francis/Peoria Radiology Research and Education Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Feezor, MD
Organizational Affiliation
University of Florida Health-Shands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abrazo Arrowhead Campus
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Florida Health - Shands
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Miami Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Coastal Vascular and Interventional
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
OSF St. Francis/Peoria Radiology Research and Education Foundation
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
MedStar Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Stony Brook Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
North Carolina Memorial Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Methodist Hospital - Smith Tower
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
S016 6YD
Country
United Kingdom
Facility Name
The Royal Liverpool University Hospital
City
Liverpool
State/Province
Meyerside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

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Cook IVC Filter Study

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