Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

University of Miami

Status and phase: Enrolling; Phase 2

Conditions: Cerebral Aneurysm

Treatments: Procedure: Endovascular treatment; Procedure: Microsurgical clipping; Drug: Sirolimus

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04141020

20190857

1R01NS111119-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Microsurgical Clipping Treated with Sirolimus

Experimental group

Description:

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.

Treatment:

Drug: Sirolimus

Procedure: Microsurgical clipping

Endovascular Treatment Treated with Sirolimus

Experimental group

Description:

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.

Treatment:

Drug: Sirolimus

Procedure: Endovascular treatment