US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

Exclusion Criteria

• •1. Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
• •2. Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
• •3. Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.
• •4. Contraindication to anticoagulants or anti-platelet medications
• •5. Stenosis of the target IA's parent vessel is \>50%
• •6. Anticoagulation medications (e.g., warfarin) that cannot be discontinued
• •7. Acute / chronic renal failure (unless on dialysis) and/or creatinine \> 2.00 mg/dl or \> 182 μmol/L
• •8. Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
• •9. Clinical, angiographic or CT evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
• •10. Conditions placing them at high risk for ischemic stroke or had exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60-days.
• •11. Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder).
• •12. modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable).
• •13. SAH from a non-index aneurysm or any other intracranial hemorrhage within 90 days.
• •14. Physical, neurologic or psychiatric conditions which precluded his/her ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
• •15. Pregnant, breastfeeding or planning pregnancy in the next 2 years
• •16. Subject is enrolled in another device or drug study in which participation could confound study results.
• •17. Life expectancy of less than 2 years due to an illness or condition other than the index intracranial aneurysm.