EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)

Exclusion Criteria

• •1. Subject's vessel characteristics preclude safe endovascular access to the aneurysm to treat with the Pipeline™ Shield Device.
• •2. Subject has aneurysm vessel characteristics that would preclude the device from fully conforming to the parent vessel to reduce any risk of embolic complications, retreatment, or device movement.
• •3. Subject has true bifurcation or aneurysms with vessels that cannot be separated from the fundus with placement of the study device.
• •4. Subject with intraparenchymal hemorrhage.
• •5. Subject is unable to undergo nasogastric/orogastric tube placement prior to device placement.
• •6. Subject has a pre-morbid mRS \>2.
• •7. Subject requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm.
• •8. Subject has a target ruptured aneurysm that is thought to be mycotic, including those caused by left atrial myxoma, or subject has an active systemic bacterial infection.
• •9. Subject with a requirement for continuous anti-coagulation.
• •10. Subject has a malignant brain tumor or vascular malformation (e.g. arteriovenous malformation).
• •11. Subject's target ruptured aneurysm has not been determined by the treating physician to be the source of SAH.
• •12. Subject with known allergy to platinum or cobalt chromium alloy (including the major elements platinum, cobalt, chromium, nickel or molybdenum).
• •13. Subject has a known hypersensitivity to ticagrelor or aspirin.
• •14. Subject is unable to undergo DSA or DSA is determined unsuitable by the treating physician.
• •15. Subject has a serious or life-threatening comorbidity that could confound study results.
• •16. Subject is at high risk of noncompliance per treating physician due to reasons including but not limited to a history of substance abuse.
• •17. Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 24 months.
• •18. Subject is pregnant, or breastfeeding at the time of admission or plans to become pregnant during their participation in the study.
• •19. Subject is participating in another clinical study at the time of enrollment.
• •20. Presumed septic embolus, or suspicion of microbial superinfection.
• •21. Subject with a known COVID-19 viral infection, confirmed by testing.
• •22. Subject in whom a pre-existing stent is in place in the parent artery at target aneurysm location.