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Crux Biomedical IVC Filter - Evaluation of the Crux Inferior Vena Cava Filter System (Retrieve)

This study is currently recruiting participants.
Study NCT00605332.   Last updated on January 30, 2008.   Information provided by Crux Biomedical

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Crux Biomedical IVC Filter - Evaluation of the Crux Inferior Vena Cava Filter System (Retrieve)
Official Title † Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System - ("Retrieve")
Brief Summary

This is an open label, non-randomized, prospective, multicenter study.
Detailed Description
Study Phase Phase II
Study Type † Interventional
Study Design † Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure † Primary Efficacy Objective: To describe the clinical utility of the Crux IVCF by the following criteria: Absence of a recurrent PE and IVC thrombosis related to the Crux IVCF. [ Time Frame: 30 days post implant, 30 days post retrieval. Patients with indwelling filters will return 1 and 6 months post implant procedure. ] [ Designated as safety issue: No ]
Secondary Outcome Measure † Primary Safety Objective: To estimate the proportion of patients who experience device/procedure related complications associated with the Crux IVCF. [ Time Frame: 30 days post implant procedure and 30 days post retrieval procedure. Patients with indwelling filters will return 1 and 6 months post implant procedure. ] [ Designated as safety issue: Yes ]
Condition † Pulmonary Embolism
Intervention † Device: inferior vena cava filter
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 104
Start Date † October 2007
Completion Date October 2008
Eligibility Criteria †

Inclusion Criteria:

Patients for this study must meet the following inclusion criteria to be eligible for enrollment:

  1. The patient is >18 years of age.

  2. Patient is considered a candidate for the IVCF under one of the following indications:

    • Proven PE
    • Recurrent PE despite adequate anticoagulation
    • Contraindication to anticoagulation
    • Inability to achieve/maintain therapeutic anticoagulation
    • Iliocaval DVT
    • Large, free-floating proximal (i.e. ileofemoral) 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 anticoagulant medications
    • High risk of injury worsened by anticoagulation (e.g., ataxia, falls)
    • Multi-trauma patient with high risk of PE
    • Surgical patients at high risk of PE
    • Medical condition with high risk of PE
  3. Patient has a vena cava diameter of 17-28mm.
  4. The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
  5. The patient is willing to be available for the appropriate follow-up for the duration of the study.
  6. The patient has suitable IVC anatomy that would allow infra-renal placement of the filter.

Exclusion Criteria:

Patients who have ANY of the following exclusion criteria are NOT eligible for the study:

  1. The patient has one of the following conditions:

    • Renal vein thrombosis
    • IVC thrombosis extending to renal veins
    • Duplicate IVC
    • Gonadal vein thrombosis
    • Requires supra-renal filter placement
  2. The patient has an uncontrolled infectious disease.
  3. The patient is at risk for aseptic PE.
  4. Patient has uncontrollable coagulopathy.
  5. Patient has an existing IVCF.
  6. The patient has a life expectancy of less than 6 months.
  7. The patient is pregnant.
  8. The patient has a condition that inhibits radiographic visualization of the IVC.
  9. The patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol.
  10. The patient has a known hypersensitivity to contrast which cannot be pre-treated.
  11. The patient's access vessels preclude safe insertion of the delivery system.
  12. The patient is participating in another device or drug study. Patient must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this trial. The patient may only be enrolled in this study once.
  13. The patient is unable and/or unwilling to cooperate with study procedures or required follow-up visits.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00605332
Organization ID Retrieve
Secondary IDs †† G070035
Study Sponsor † Crux Biomedical
Collaborators ††
Investigators †
Principal Investigator:     David Rosenthal, MD     Atlanta Vascular Specialists    
Study Director:     Mel Schatz     Crux Biomedical    
Study Director:     Roberta Hines     Northwest Clinical Research Group    
Information Provided By Crux Biomedical
Verification Date January 2008
First Received Date † January 2, 2008
Last Updated Date January 30, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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