RecruitingPhase 2NCT04141020

Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Sponsor

University of Miami

Enrollment

80 participants

Start Date

Oct 27, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

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)
≥ 18 years of age
Willing and able to give informed consent

\) 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.

Interested in this trial?

Get notified about updates and connect with the research team.

PROCEDUREMicrosurgical clipping

Standard of care microsurgical clipping of an unruptured cerebral artery aneurysm.

PROCEDUREEndovascular treatment

Standard of care endovascular treatment of an unruptured cerebral artery aneurysm.

DRUGSirolimus

Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.

University of Miami

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT04141020