NCT04141020PHASE2Recruiting
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
University of Miami
Start Date
10/27/2021
Completion Date
11/1/2026
Summary
The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
PROCEDURE
Microsurgical clipping
PROCEDURE
Endovascular treatment
DRUG
Sirolimus
Conditions
Cerebral Aneurysm
Locations
University of Miami
Miami, Florida 33136
United States