Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Conditions

• Cerebral Aneurysm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Microsurgical clipping — PROCEDURE
  Standard of care microsurgical clipping of an unruptured cerebral artery aneurysm.
• Endovascular treatment — PROCEDURE
  Standard of care endovascular treatment of an unruptured cerebral artery aneurysm.
• Sirolimus — DRUG
  Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.

Study Details

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

Key Dates

Start date

Oct 27, 2021

Status verified

Mar 2026

Primary completion

Nov 1, 2026

Completion

Nov 1, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

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.

Primary Outcome Measure

Change in gene expression from control arteries. [ Time Frame: Day 18 ]

Central Contacts

• Jayro Toledo, MD
  305-243-8044
  [email protected]

Locations (1)

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