Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3 ("RETRIEVE 3")

Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3

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 must provide informed consent At least one of the following conditions -
• Proven PE
• Recurrent PE despite adequate
• 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
• Protection during thrombolysis for iliocaval DVT
• PE with limited cardiopulmonary reserve
• Poor compliance with anticoagulation medication
• High risk of injury worsening on anticoagulation
• Multi-trauma patient with high risk of PE
• Surgical patients at high risk of PE
• Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is 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 the renal veins
  • Duplicate IVC
  • Gonadal vein thrombosis
  • Requires supra-renal placement

• Vena cava diameter of 17-28mm

• 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 same insertion of delivery system

• Participation in another drug or device trial

• Unable or unwilling to cooperate with study procedures or required follow-up visits