Crux Biomedical Vena Cava Filter Study - United States

Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2

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

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

  • 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:

• 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