Intracranial AneurysmHUIQENCT06147102
The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study
An observational study of Intracranial Aneurysm, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
A research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Surgery and Endovascular
- Type of treatment
- Surgery or procedure
- How many people
- 173 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2023to 31 Dec 2027
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients undergoing endovascular or surgical treatment for an unruptured intracranial aneurysm at Helsinki university hospital
Who may be able to join
- All patients with an unruptured intracranial aneurysm undergoing treatment
Who cannot join
- Arteriovenous malformation related intracranial aneurysm
- Moyamoya-disease related intracranial aneurysm
- Ruptured intracranial aneurysm
Trial locations and contacts
1 site in 1 country.
About this study
A research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. All consecutive patients with a non-ruptured intracranial aneurysms treated at Helsinki University Hospital will be included. Safety is measured by postoperative magnetic resonance imaging (MRI) taken 1-3 days after the treatment, treatment-related complications and functional outcome at three months. Effectiveness is measured by angiographic results and assessment of long-term bleeding from the treated aneurysm. Other outcomes include risk of developing epilepsy, getting a new stroke, and dementia on long-term follow-up.
- Conditions
- Intracranial Aneurysm
- Being tested
- Surgery, Endovascular
- Keywords
- intracranial aneurysm, surgery, neurosurgery, endovascular, interventional neuroradiology, neurointervention, unruptured
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgical treatment for the unruptured intracranial aneurysm
EndovascularProcedure or surgery
Endovascular treatment for the unruptured intracranial aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment | Patients with unruptured intracranial aneurysms treated endovascularly Receives: Procedure: Endovascular | |
| Surgical treatment | Patients with unruptured intracranial aneurysms treated surgically Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
New ischemic lesion on postoperative MRI
Diffusion-Weighted Imaging lesion
Measured: 1-3 days
Secondary outcomes (8)
Neurological symptom
New procedure-related neurological symptom
Measured: 3 months
Return to work
Days from intervention to return to work
Measured: 3 months
Functional outcome
modified Rankin Scale (mRS going from 0 [no sympyoms] to 6 death])
Measured: 3 months
Aneurysm occlusion on angiography
Rate of occluded vs. incompletely occluded aneurysms. Assessed through digital subtraction angiography, CTA or MRA. Routine controls for endovascularly treated patients 6mo, 2y, and if needed 5y. Routinely assessed by a postoperative CTA for surgically treated patients.
Measured: 6mo - 5yrs
Patients with late rebleeding from the target aneurysm
Number of patients with rebleeding (subarachnoid hemorrhage [SAH]) from the treated aneurysm
Measured: up to 10 yrs
Epilepsy
Number of patients with a new diagnosis of epilepsy after aneurysm treatment
Measured: up to 10 yrs
Dementia
Number of patients with a new diagnosis of dementia after aneurysm treatment
Measured: up to 10 yrs
Other stroke than aneurysm bleed
Number of patients with a new stroke (other than SAH from the treated aneurysm) after aneurysm treatment
Measured: up to 10 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahul Raj, Helsinki University Central Hospital
- Investigators
- Rahul Raj, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147102
- Sponsor's protocol ID
- HUS/216/2023
- Acronym
- HUIQE
- Status last verified
- Oct 2024
- First submitted
- 20 Nov 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing regulated by the Secondary Use of Health And Social Data Act in Finland.
Publications
Raj R, Numminen J, Niemela M, Korja M. Technique and device specific diffusion-weighted imaging detected ischemic lesions and occlusion outcomes in endovascular treatment of unruptured aneurysms. Acta Neurochir (Wien). 2026 Jun 4;168(1):182. doi: 10.1007/s00701-026-06934-z.
PubMed 42240692Raj R, Numminen J, Huhtakangas J, Nurminen V, Lehecka M, Laakso A, Kivipelto L, Niemela M, Korja M. The Helsinki Unruptured Intracranial Aneurysm Quality of Care study: a prospective observational study. J Neurosurg. 2025 Dec 5;144(3):507-516. doi: 10.3171/2025.7.JNS25775. Print 2026 Mar 1.
PubMed 41349033
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study
- ClinicalTrials.gov ID
- NCT06147102
- Acronym / sponsor ID
- HUIQE / HUS/216/2023
- Conditions
- Intracranial Aneurysm
- Keywords
- intracranial aneurysm, surgery, neurosurgery, endovascular, interventional neuroradiology, neurointervention, unruptured
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Nov 2023 (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.
A research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. All consecutive patients with a non-ruptured intracranial aneurysms treated at Helsinki University Hospital will be included. Safety is measured by postoperative magnetic resonance imaging (MRI) taken 1-3 days after the treatment, treatment-related complications and functional outcome at three months. Effectiveness is measured by angiographic results and assessment of long-term bleeding from the treated aneurysm. Other outcomes include risk of developing epilepsy, getting a new stroke, and dementia on long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment | – | Procedure: EndovascularPatients with unruptured intracranial aneurysms treated endovascularly |
| Surgical treatment | – | Procedure: SurgeryPatients with unruptured intracranial aneurysms treated surgically |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing endovascular or surgical treatment for an unruptured intracranial aneurysm at Helsinki university hospital
Key inclusion criteria (1 listed)
- All patients with an unruptured intracranial aneurysm undergoing treatment
Key exclusion criteria (3 listed)
- Arteriovenous malformation related intracranial aneurysm
- Moyamoya-disease related intracranial aneurysm
- Ruptured intracranial aneurysm
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 |
|---|---|---|
| SurgerySurgical treatment for the unruptured intracranial aneurysm | Procedure or surgery | Surgical treatment |
| EndovascularEndovascular treatment for the unruptured intracranial aneurysm | Procedure or surgery | Endovascular treatment |
Primary outcome
New ischemic lesion on postoperative MRI
Time frame: 1-3 days
Diffusion-Weighted Imaging lesion
8 secondary outcomes
Neurological symptom
Time frame: 3 months
Return to work
Time frame: 3 months
Functional outcome
Time frame: 3 months
Aneurysm occlusion on angiography
Time frame: 6mo - 5yrs
Patients with late rebleeding from the target aneurysm
Time frame: up to 10 yrs
Epilepsy
Time frame: up to 10 yrs
Dementia
Time frame: up to 10 yrs
Other stroke than aneurysm bleed
Time frame: up to 10 yrs
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 10 Oct 2024.
- Derived from this study: PubMed 42240692Raj R, Numminen J, Niemela M, Korja M. Technique and device specific diffusion-weighted imaging detected ischemic lesions and occlusion outcomes in endovascular treatment of unruptured aneurysms. Acta Neurochir (Wien). 2026 Jun 4;168(1):182. doi: 10.1007/s00701-026-06934-z.
- Derived from this study: PubMed 41349033Raj R, Numminen J, Huhtakangas J, Nurminen V, Lehecka M, Laakso A, Kivipelto L, Niemela M, Korja M. The Helsinki Unruptured Intracranial Aneurysm Quality of Care study: a prospective observational study. J Neurosurg. 2025 Dec 5;144(3):507-516. doi: 10.3171/2025.7.JNS25775. Print 2026 Mar 1.
- Individual participant dataSharing planned: Undecided. Data sharing regulated by the Secondary Use of Health And Social Data Act in Finland.
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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.
Rahul Raj, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Helsinki University Central Hospital at 1 site in Finland.
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 1 inclusion and 3 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 10 Oct 2024. 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 Finland. 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.
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?
New ischemic lesion on postoperative MRI (time frame: 1-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147102, which also lists 2 linked publications.
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 10 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.