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.
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