Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4 (RETRIEVE 4)

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: NCT01120535
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 : 20 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 4 (RETRIEVE 4)
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

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. Rates of complications related to vena cava filter use. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patient has a permanent or temporary risk of Pulmonary Embolism.
  • Patient must provide informed consent At least one of the following conditions -
  • Proven PE
  • Recurrent PE despite adequate
  • 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
  • Protection during thrombolysis for iliocaval DVT
  • PE with limited cardiopulmonary reserve
  • Poor compliance with anticoagulation medication
  • High risk of injury worsening on anticoagulation
  • Multi-trauma patient with high risk of PE
  • Surgical patients at high risk of PE
  • Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is 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 the renal veins
    • Duplicate IVC
    • Gonadal vein thrombosis
    • Requires supra-renal placement
  • Vena cava diameter of 17-28mm
  • 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 same 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): NCT01120535

Royal Brisbane Womens Hospital
Brisbane, Australia
The Alfred Hospital
Melbourne, Australia
New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
Crux Biomedical

Additional Information:
Responsible Party: Crux Biomedical Identifier: NCT01120535     History of Changes
Other Study ID Numbers: Crux04
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: June 30, 2014
Last Verified: February 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