NCT04141020 Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
| NCT ID | NCT04141020 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Miami |
| Condition | Cerebral Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-10-27 |
| Primary Completion | 2026-11-01 |
Trial Parameters
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Brief Summary
The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.
Eligibility 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