Status and phase
Conditions
Treatments
About
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.
Enrollment
Sex
Ages
Volunteers
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
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
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
Primary purpose
Allocation
Interventional model
Masking
88 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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