Crux Biomedical Vena Cava Filter Study - United States

Completed · Phase 3

Conditions studied: Pulmonary Embolism

In brief

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

Key facts

Study ID

NCT01120509

Run by

Crux Biomedical

People needed

88

Starts

2010-06-01

Expected to finish

2012-01-01

Last updated by the study team

2014-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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