Recruiting
Phase 2

Sirolimus

Sponsor:

University of Miami

Code:

NCT04141020

Conditions

Cerebral Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Microsurgical clipping

Endovascular treatment

Sirolimus

Study Details

Brief summary:

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

Conditions

Cerebral Aneurysm

Study ID

NCT04141020

Start date

Oct 27, 2021

Status verified date

Mar, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 condition, which in the opinion of the investigator could affect assessment of the safety or efficacy of study intervention.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • Change in gene expression from control arteries. [ Time Frame: Day 18 ]
  • Change in gene expression between blood samples. [ Time Frame: Day 18 ]
  • Change in gene expression. [ Time Frame: Day 18 ]

Central Contacts and Locations

Central contacts

Jayro Toledo, MD

305-243-8044j.toledo2@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Jayro Toledo, MD

305-243-8044j.toledo2@med.miami.edu

Principal Investigator:

Robert M Starke, M.D.

More Information

Sponsor

University of Miami

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-23.