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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crux Biomedical
ClinicalTrials.gov Identifier:
NCT01120509
First received: April 29, 2010
Last updated: June 26, 2014
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Pulmonary Embolism
Device: Inferior Vena Cava Filter
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2

Resource links provided by NLM:


Further study details as provided by Crux Biomedical:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    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:
  • Retrieval Success [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Filter Migration [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • VCF Thrombus [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Device Integrity [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment: 88
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crux Vena Cava Filter System
Subjects at risk for Pulmonary Embolism
Device: Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120509

Locations
United States, California
University of California at Irvine Medical Center
Orange, California, United States, 92868
St. Joseph's Hospital
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
Investigators
Principal Investigator: Robert Mendes, MD University Hospital, Augusta, Georgia, USA
  More Information

Additional Information:
No publications provided

Responsible Party: Crux Biomedical
ClinicalTrials.gov Identifier: NCT01120509     History of Changes
Other Study ID Numbers: Crux02
Study First Received: April 29, 2010
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 29, 2014