Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

• Status: Recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

1. Undergoing one of the following procedures at Jackson Memorial Hospital:

• Clipping of an unruptured cerebral artery aneurysm

• Endovascular treatment of unruptured cerebral aneurysms (including those receiving coiling)

2. ≥ 18 years of age

3. Willing and able to give informed consent

Exclusion Criteria:

1) Subjects meeting any of the following criteria will be excluded:

• Dissecting, traumatic, or mycotic brain aneurysm.

• Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.

• Women who are breastfeeding.

• Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.

• Patients with known Human Immunodeficiency Virus (HIV) infection or other known immunodeficiency.

• Patient with renal or liver failure

• Interstitial pneumonitis

• History of lymphoma

• History of skin cancer

• Hypersensitivity to sirolimus

• Severe or unstable concomitant condition disease or chronic condition, which in the opinion of the investigator could affect assessment of the safety or efficacy of study intervention.