Cook IVC Filter Study

NCT02046096 | Completed Results FDA Device

• 1 other identifier: 12-018
• Study Type: interventional
• Target: 473
• Locations: 3 countries
• Sites: 28

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).

Conditions

Pulmonary Embolism

Keywords

Venous thrombosis; pulmonary embolism; vena cava, inferior; vena cava filters; venous thromboembolism

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling

  12 months

• Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)

  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.

  12 months

Other Outcomes (1)

• Filter Retrieval Rate

  2 years

Study Arms (2)

Günther Tulip® Vena Cava Filter

EXPERIMENTAL

Günther Tulip® Vena Cava Filter

Device: Günther Tulip® Vena Cava Filter

Cook Celect® Vena Cava Filters

EXPERIMENTAL

Cook Celect® Vena Cava Filters

Device: Cook Celect® Vena Cava Filters

Interventions

Günther Tulip® Vena Cava Filter DEVICE

Temporary or permanent filter placement for the prevention of pulmonary embolism

Günther Tulip® Vena Cava Filter

Cook Celect® Vena Cava Filters DEVICE

Temporary or permanent filter placement for the prevention of pulmonary embolism

Cook Celect® Vena Cava Filters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (28)

Abrazo Arrowhead Campus

Phoenix, Arizona, 85021, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Florida Health - Shands

Gainesville, Florida, 32610, United States

Location

Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Coastal Vascular and Interventional

Pensacola, Florida, 32504, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

OSF St. Francis/Peoria Radiology Research and Education Foundation

Peoria, Illinois, 61637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

North Carolina Memorial Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Methodist Hospital - Smith Tower

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22904, United States

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Southampton General Hospital

Southampton, Hampshire, S016 6YD, United Kingdom

Location

The Royal Liverpool University Hospital

Liverpool, Meyerside, L7 8XP, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Thromboembolism

Results Point of Contact

• Title: Alan Saunders, MS, RAC; Manager, Biostatistics
• Organization: Cook Research Incorporated

Alan.Saunders@CookMedical.com

765-463-7537

Study Officials

• H. Bob Smouse, MD

  OSF St. Francis/Peoria Radiology Research and Education Foundation

  PRINCIPAL INVESTIGATOR

• Robert Feezor, MD

  University of Florida Health-Shands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: January 1, 2014
• Primary Completion: December 18, 2018
• Study Completion: August 9, 2019
• Last Updated: January 20, 2022
• Results First Posted: January 11, 2022

Record last verified: 2022-01

Locations

AU (1); US (22); GB (5)