Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2010-06-30
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Crux Vena Cava Filter System
Subjects at risk for Pulmonary Embolism
Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.
Interventions
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Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Crux Biomedical
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Mendes, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Augusta, Georgia, USA
Locations
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St. Joseph's Hospital
Orange, California, United States
University of California at Irvine Medical Center
Orange, California, United States
Univeristy of California at Davis Medical Center
Sacramento, California, United States
Christiana Care
Newark, Delaware, United States
University of Florida Medical Center
Gainesville, Florida, United States
Atlanta Medical Center
Atlanta, Georgia, United States
University Hospital
Augusta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
St. Francis Hospital
Peoria, Illinois, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Albany Medical Center
Albany, New York, United States
Upstate Medical Center
Syracuse, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Jobst Vascular Institute
Toledo, Ohio, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Countries
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Related Links
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Smouse H, Mendes R, Bosiers M et al. The RETRIEVE Trial: Safety and Effectiveness of the Retrieval Crux Vena Cava Filter. JVIR 2013; 24:609-621.
Other Identifiers
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Crux02
Identifier Type: -
Identifier Source: org_study_id