Crux Biomedical IVC Filter - Evaluation of the Crux Inferior Vena Cava Filter System (Retrieve)

Inclusion criteria

Patients for this study must meet the following inclusion criteria to be eligible for enrollment:

• The patient is >18 years of age.
• Patient is considered a candidate for the IVCF under one of the following indications:

• Proven PE
• Recurrent PE despite adequate anticoagulation
• Contraindication to anticoagulation
• Inability to achieve/maintain therapeutic anticoagulation
• Iliocaval DVT
• Large, free-floating proximal (i.e. ileofemoral) 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 anticoagulant medications
• High risk of injury worsened by anticoagulation (e.g., ataxia, falls)
• Multi-trauma patient with high risk of PE
• Surgical patients at high risk of PE
• Medical condition with high risk of PE
• Patient has a vena cava diameter of 17-28mm.
• The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
• The patient is willing to be available for the appropriate follow-up for the duration of the study.
• The patient has suitable IVC anatomy that would allow infra-renal placement of the filter.

Exclusion criteria

Patients who have ANY of the following exclusion criteria are NOT eligible for the study:

• The patient has one of the following conditions:

• Renal vein thrombosis
• IVC thrombosis extending to renal veins
• Duplicate IVC
• Gonadal vein thrombosis
• Requires supra-renal filter placement
• The patient has an uncontrolled infectious disease.
• The patient is at risk for aseptic PE.
• Patient has uncontrollable coagulopathy.
• Patient has an existing IVCF.
• The patient has a life expectancy of less than 6 months.
• The patient is pregnant.
• The patient has a condition that inhibits radiographic visualization of the IVC.
• The patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol.
• The patient has a known hypersensitivity to contrast which cannot be pre-treated.
• The patient's access vessels preclude safe insertion of the delivery system.
• The patient is participating in another device or drug study. Patient must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this trial. The patient may only be enrolled in this study once.
• The patient is unable and/or unwilling to cooperate with study procedures or required follow-up visits.