Study of Sirolimus Impact on Molecular Changes in Unruptured Cerebral Aneurysms During Microsurgical Clipping or Endovascular Treatment

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.

Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms