Cerebral AneurysmPhase 2NCT04141020
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
A Phase 2 study testing Microsurgical clipping, Endovascular treatment and Sirolimus in people with Cerebral Aneurysm, run by University of Miami at 1 site in United States.
Trial summary
The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Microsurgical clipping, Endovascular treatment and Sirolimus
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2021to 1 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- ≥ 18 years of age
- Willing and able to give informed consent
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.
- Conditions
- Cerebral Aneurysm
- Being tested
- Microsurgical clipping, Endovascular treatment, Sirolimus
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical clippingProcedure or surgery
Standard of care microsurgical clipping of an unruptured cerebral artery aneurysm.
Endovascular treatmentProcedure or surgery
Standard of care endovascular treatment of an unruptured cerebral artery aneurysm.
SirolimusDrug
Also called Rapamune
Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Microsurgical Clipping Treated with Sirolimus | Experimental | 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. Receives: Procedure: Microsurgical clipping; Drug: Sirolimus |
| Endovascular Treatment Treated with Sirolimus | Experimental | 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. Receives: Procedure: Endovascular treatment; Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gene expression from control arteries.
Change in gene expressions will be reported as fold change from control arteries: superficial temporal artery from the same patient and the intracerebral temporal lobe artery from a different patient. Genes to be evaluated are endothelial cell marker genes such as Cluster of Differentiation (CD) 34, CD31, Von Willebrand Factor (vWF), E-selectin, Vascular Endothelial (VE)-cadherin and Endothelial Nitric Oxide Synthase (eNOS) and pro-inflammatory-matrix remodeling proliferation genes such as Matrix Metallopeptidase (MMP)3 and MMP9, Vascular Cell Adhesion Molecule (VCAM)-1, Intercellular Adhesion Molecule (ICAM), Inducible Nitric Oxide Synthase (iNOS), Membrane Cofactor Protein (MCP) and Interleukin (IL)-1ß.
Measured: Day 18
Change in gene expression between blood samples.
Change in gene expressions will be reported as fold change of intra-aneurysmal blood to peripheral blood from the same patient. Genes to be evaluated are endothelial cell marker genes (CD34, CD31, vWF, E-selectin, VE-cadherin, and eNOS) and pro-inflammatory-matrix remodeling proliferation genes (MMP3, MMP9, VCAM-1, ICAM, iNOS, MCP, and IL-1ß).
Measured: Day 18
Change in gene expression.
Fold change of IL-2 expression and expression of endothelial cell marker genes (CD34, CD31, vWF, E-selectin, VE-cadherin, and eNOS) and pro-inflammatory-matrix remodeling proliferation genes (MMP3, MMP9, VCAM-1, ICAM, iNOS, MCP, and IL-1ß) will be evaluated between sirolimus treated to non-treated patients.
Measured: Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start27 Oct 2021
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Starke, University of Miami
- Investigators
- Robert M Starke, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141020
- Sponsor's protocol ID
- 20190857
- Other IDs
- 1R01NS111119-01A1
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2019
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
- ClinicalTrials.gov ID
- NCT04141020
- Acronym / sponsor ID
- 20190857
- Conditions
- Cerebral Aneurysm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microsurgical Clipping Treated with Sirolimus | Experimental | Procedure: Microsurgical clipping, Drug: SirolimusParticipants 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. |
| Endovascular Treatment Treated with Sirolimus | Experimental | Procedure: Endovascular treatment, Drug: SirolimusParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing one of the following procedures at Jackson Memorial Hospital:
- ≥ 18 years of age
- Willing and able to give informed consent
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microsurgical clippingStandard of care microsurgical clipping of an unruptured cerebral artery aneurysm. | Procedure or surgery | Microsurgical Clipping Treated with Sirolimus |
| Endovascular treatmentStandard of care endovascular treatment of an unruptured cerebral artery aneurysm. | Procedure or surgery | Endovascular Treatment Treated with Sirolimus |
| SirolimusAlso: RapamuneDaily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician. | Drug | Endovascular Treatment Treated with Sirolimus, Microsurgical Clipping Treated with Sirolimus |
Primary outcome
Change in gene expression from control arteries.
Time frame: Day 18
Change in gene expressions will be reported as fold change from control arteries: superficial temporal artery from the same patient and the intracerebral temporal lobe artery from a different patient. Genes to be evaluated are endothelial cell marker genes such as Cluster of Differentiation (CD) 34, CD31, Von Willebrand Factor (vWF), E-selectin, Vascular Endothelial (VE)-cadherin and Endothelial Nitric Oxide Synthase (eNOS) and pro-inflammatory-matrix remodeling proliferation genes such as Matrix Metallopeptidase (MMP)3 and MMP9, Vascular Cell Adhesion Molecule (VCAM)-1, Intercellular Adhesion Molecule (ICAM), Inducible Nitric Oxide Synthase (iNOS), Membrane Cofactor Protein (MCP) and Interleukin (IL)-1ß.
Change in gene expression between blood samples.
Time frame: Day 18
Change in gene expressions will be reported as fold change of intra-aneurysmal blood to peripheral blood from the same patient. Genes to be evaluated are endothelial cell marker genes (CD34, CD31, vWF, E-selectin, VE-cadherin, and eNOS) and pro-inflammatory-matrix remodeling proliferation genes (MMP3, MMP9, VCAM-1, ICAM, iNOS, MCP, and IL-1ß).
Change in gene expression.
Time frame: Day 18
Fold change of IL-2 expression and expression of endothelial cell marker genes (CD34, CD31, vWF, E-selectin, VE-cadherin, and eNOS) and pro-inflammatory-matrix remodeling proliferation genes (MMP3, MMP9, VCAM-1, ICAM, iNOS, MCP, and IL-1ß) will be evaluated between sirolimus treated to non-treated patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Starke, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Microsurgical clipping, Endovascular treatment and Sirolimus in people with Cerebral Aneurysm, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gene expression from control arteries. (time frame: Day 18). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.