Crux Biomedical Vena Cava Filter Study - United States (RETRIEVE 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01120509
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : June 30, 2014
Information provided by (Responsible Party):
Crux Biomedical

Brief Summary:
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Device: Inferior Vena Cava Filter Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2
Study Start Date : June 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Crux Vena Cava Filter System
Subjects at risk for Pulmonary Embolism
Device: Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.

Primary Outcome Measures :
  1. Clinical Success [ Time Frame: 6 Months ]
    Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.

Secondary Outcome Measures :
  1. Retrieval Success [ Time Frame: 6 Months ]
  2. Filter Migration [ Time Frame: 6 Months ]
  3. VCF Thrombus [ Time Frame: 6 Months ]
  4. Device Integrity [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has a permanent or temporary risk of Pulmonary Embolism
  • Patient or legal guardian must provide written informed consent
  • At least one of the following conditions

    • Proven PE
    • Recurrent PE despite adequate anticoagulation
    • Contraindication to anticoagulation
    • Inability to achieve/maintain therapeutic anticoagulation
    • Iliocaval DVT
    • Large, free-floating proximal DVT
    • Massive PE treated with thrombolysis/thrombectomy
    • Chronic PE treated with thrombectomy
    • Procetion during thrombolysis for iliocaval DVT
    • PE with limited cardiopulmonary reserve
    • Poor compliance with anticoagulation medication
    • High risk of injury worsend by anticoagulation
    • Multi-trauma patient with high risk of PE
    • Surgical patients at high risk of PE
    • Medical condition with high risk of PE
  • Patient has documented vena cava diameter of 17-28mm
  • Patient has IVC anatomy suitable for infra-renal placement
  • Patient willing to be available for the appropriate follow up.

Exclusion Criteria:

  • Age <18 years old
  • Patient has any one of the following conditions

    • Renal vein thrombosis
    • IVC thrombosis extending to te renal veins
    • Duplicate IVC
    • Gonadal vein thrombosis
    • Requires supra-renal placement
  • Uncontrolled infectious disease
  • Risk of aseptic PE
  • Uncontrolled coagulopathy
  • Existing inferior vena cava filter implant
  • Life expectancy less than 6 months
  • Pregnant or planning a pregnancy in the next 6 months
  • Condition that inhibits radiographic visualization of the IVC
  • Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
  • Known hypersensitivity to contract which cannot be pretreated
  • Access vessels preclude safe insertion of delivery system
  • Participation in another drug or device trial
  • Unable or unwilling to cooperate with study procedures or required follow-up visits

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 identifier (NCT number): NCT01120509

United States, California
St. Joseph's Hospital
Orange, California, United States, 92868
University of California at Irvine Medical Center
Orange, California, United States, 92868
Univeristy of California at Davis Medical Center
Sacramento, California, United States, 95817
United States, Delaware
Christiana Care
Newark, Delaware, United States
United States, Florida
University of Florida Medical Center
Gainesville, Florida, United States, 32610
United States, Georgia
Atlanta Medical Center
Atlanta, Georgia, United States, 30312
University Hospital
Augusta, Georgia, United States, 30901
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
St. Francis Hospital
Peoria, Illinois, United States, 61637
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Upstate Medical Center
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Jobst Vascular Institute
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States
Sponsors and Collaborators
Crux Biomedical
Principal Investigator: Robert Mendes, MD University Hospital, Augusta, Georgia, USA

Additional Information:
Responsible Party: Crux Biomedical Identifier: NCT01120509     History of Changes
Other Study ID Numbers: Crux02
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: June 30, 2014
Last Verified: August 2012

Keywords provided by Crux Biomedical:
Vena Cava
Vena Cava Filter
Pulmonary Embolism
Venous Thromboembolism
Risk of Pulmonary Embolism

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases