Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
NCT ID: NCT04141020
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2021-10-27
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Microsurgical Clipping Treated with Sirolimus
Participants undergoing standard of care microsurgical clipping of unruptured cerebral aneurysm will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to surgery.
Microsurgical clipping
Standard of care microsurgical clipping of an unruptured cerebral artery aneurysm.
Sirolimus
Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.
Endovascular Treatment Treated with Sirolimus
Participants undergoing standard of care endovascular treatment of unruptured cerebral aneurysm procedure will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to procedure.
Endovascular treatment
Standard of care endovascular treatment of an unruptured cerebral artery aneurysm.
Sirolimus
Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.
Interventions
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Microsurgical clipping
Standard of care microsurgical clipping of an unruptured cerebral artery aneurysm.
Endovascular treatment
Standard of care endovascular treatment of an unruptured cerebral artery aneurysm.
Sirolimus
Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Miami
OTHER
Responsible Party
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Robert Starke
Assistant Professor
Principal Investigators
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Robert M Starke, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20190857
Identifier Type: -
Identifier Source: org_study_id
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