Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System

Exclusion Criteria

• •1. Patient has any one of the following conditions:
• •1. Thrombus in the iliac veins or the IVC that precludes access to appropriate placement of the Crux Filter
• •2. Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC
• •3. Known duplicated or left-sided IVC
• •4. Known IVC transverse diameter at target lower renal ostia \> 28mm or \< 17mm
• •5. Known extrinsic compression from abdominal or pelvic mass
• •6. Known tumor thrombus involving the central venous system
• •7. Uncontrolled sepsis, infection or persistent bacteremia
• •8. Patient is at risk for septic pulmonary embolism
• •9. Patient has an existing implanted filter in the IVC or superior vena cava (SVC) or underwent filter retrieval in previous 60 days.
• •10. Patient has uncontrollable or active coagulopathy or known uncorrectable bleeding diathesis
• •11. Patient has a condition that inhibits radiographic visualization of the IVC for post-deployment assessment
• •2. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol (nickel-titanium)
• •3. Patients unwilling or unable to comply with the protocol
• •4. Patients with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated
• •5. Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)
• •6. Patient is participating in another device or drug clinical trial or has participated in such trial in the 30 days prior to enrollment
• •7. Investigator considers patient to be a poor candidate for the study or believes that the patient may compromise the study, e.g., concomitant conditions (reasons will be documented)