Actively Recruiting
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
Led by University of Miami · Updated on 2026-03-23
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of Sirolimus on the molecular changes in cerebral aneurysms, focusing on unruptured aneurysms. The study aims to explore how Sirolimus influences gene expression related to these aneurysms. This Phase 2 trial is sponsored by the University of Miami and investigates underlying molecular alterations to better understand treatment impacts. Participants will receive daily oral Sirolimus tablets at a dose of 2 mg for 14 to 18 consecutive days before undergoing their standard of care procedure. Two groups are included: those having microsurgical clipping and those receiving endovascular treatment, including coiling, for unruptured cerebral aneurysms. Both groups receive the same Sirolimus treatment prior to their respective procedures. During the study, researchers will measure changes in gene expression in blood samples and control arteries by Day 18. Participants will be monitored closely before surgery or procedure while taking Sirolimus. The study involves assessments to track molecular changes and evaluates safety through careful follow-up. The trial does not include healthy volunteers and is conducted with single masking.
CONDITIONS
Brief Title
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing clipping of an unruptured cerebral artery aneurysm or endovascular treatment of unruptured cerebral aneurysms
- 18 years of age or older
- Willing and able to give informed consent
You will not qualify if you...
- Having dissecting, traumatic, or mycotic brain aneurysm
- Women who are pregnant or breastfeeding
- Positive pregnancy test (urine or blood beta-hCG)
- Any significant psychiatric or psychological disease preventing protocol completion
- Known HIV infection or other immunodeficiency
- Kidney or liver failure
- Interstitial pneumonitis
- History of lymphoma
- History of skin cancer
- Hypersensitivity to Sirolimus
- Severe or unstable chronic or concomitant disease affecting safety or study assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 to 18 days
Participants receive daily oral Sirolimus 2 mg tablets for 14 to 18 consecutive days prior to their standard of care microsurgical clipping or endovascular treatment of an unruptured cerebral artery aneurysm.
Daily medication intake and 1 procedure visit
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
J
Jayro Toledo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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