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

  • Study HIC#:2000029272
  • Last Updated:05/09/2022

The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.

  • Age22 years - 80 years
  • GenderBoth
  • Start Date02/11/2022
  • End Date02/28/2023

Trial Purpose and Description

The ELEVATE study is a prospective, multi-center, single-arm trial of the Pipeline™ Shield Device for the treatment of adults with acutely ruptured intracranial aneurysms. The primary objective of the ELEVATE study is to assess the safety and effectiveness of treatment with the Pipeline™ Shield Device of acutely ruptured intracranial aneurysms that are not amenable for clipping and coiling.

Eligibility Criteria

Inclusion Criteria:

  1. Subject has a previously untreated, wide neck, side-wall, intradural aneurysm that is deemed unfavorable for both surgical clipping and endovascular coiling, as confirmed on DSA.
  2. Subject has a ruptured intracranial aneurysm with vessel diameter suitable for treatment with the study device.
  3. Subject is ≥ 22 and ≤ 80 years of age.
  4. Subject has an acutely ruptured aneurysm with Hunt and Hess Scale 1, 2 or 3.
  5. Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent.

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.

Principal Investigator

Sub-Investigator

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