Cook IVC Filter Study

NCT ID: NCT02046096

Last Updated: 2022-01-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

473 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-08-09

Brief Summary

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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).

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Günther Tulip® Vena Cava Filter

Günther Tulip® Vena Cava Filter

Group Type EXPERIMENTAL

Günther Tulip® Vena Cava Filter

Intervention Type DEVICE

Temporary or permanent filter placement for the prevention of pulmonary embolism

Cook Celect® Vena Cava Filters

Cook Celect® Vena Cava Filters

Group Type EXPERIMENTAL

Cook Celect® Vena Cava Filters

Intervention Type DEVICE

Temporary or permanent filter placement for the prevention of pulmonary embolism

Interventions

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Günther Tulip® Vena Cava Filter

Temporary or permanent filter placement for the prevention of pulmonary embolism

Intervention Type DEVICE

Cook Celect® Vena Cava Filters

Temporary or permanent filter placement for the prevention of pulmonary embolism

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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H. Bob Smouse, MD

Role: PRINCIPAL_INVESTIGATOR

OSF St. Francis/Peoria Radiology Research and Education Foundation

Robert Feezor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida Health-Shands

Locations

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Abrazo Arrowhead Campus

Phoenix, Arizona, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

University of Florida Health - Shands

Gainesville, Florida, United States

Site Status

Miami Cardiac and Vascular Institute

Miami, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Coastal Vascular and Interventional

Pensacola, Florida, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

OSF St. Francis/Peoria Radiology Research and Education Foundation

Peoria, Illinois, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Stony Brook Medicine

Stony Brook, New York, United States

Site Status

North Carolina Memorial Hospital

Chapel Hill, North Carolina, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

The Methodist Hospital - Smith Tower

Houston, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Site Status

The Royal Liverpool University Hospital

Liverpool, Meyerside, United Kingdom

Site Status

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Hull Royal Infirmary

Hull, , United Kingdom

Site Status

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Countries

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United States Australia United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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12-018

Identifier Type: -

Identifier Source: org_study_id

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