The Helsinki Unruptured Intracranial Aneurysm Quality of... | NCT06147102

Studies
The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

NCT06147102

Sponsor

Helsinki University Central Hospital

Status

Active, not recruiting

Last Update Posted

Oct 10, 2024Actual

Enrollment

173Actual

Phase

Not provided

Conditions

Intracranial Aneurysm

Interventions

Surgery
Endovascular

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Nov 20, 2023

First Submission Date that Met QC Criteria

Nov 20, 2023

First Posted Date

Nov 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2024

Last Update Posted Date

Oct 10, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rahul Raj, Principal Investigator, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endovascular treatment		Patients with unruptured intracranial aneurysms treated endovascularly	Procedure: Endovascular
Surgical treatment		Patients with unruptured intracranial aneurysms treated surgically	Procedure: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Surgical treatment for the unruptured intracranial aneurysm	Surgical treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
New ischemic lesion on postoperative MRI	Diffusion-Weighted Imaging lesion	1-3 days

Secondary Outcomes

Measure	Description	Time Frame
Neurological symptom	New procedure-related neurological symptom	3 months
Return to work	Days from intervention to return to work

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with an unruptured intracranial aneurysm undergoing treatment

Exclusion Criteria:

Arteriovenous malformation related intracranial aneurysm
Moyamoya-disease related intracranial aneurysm
Ruptured intracranial aneurysm

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients undergoing endovascular or surgical treatment for an unruptured intracranial aneurysm at Helsinki university hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rahul Raj, MD, PhD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital		Helsinki	Uusimaa	00029 HUS	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41349033	Derived	Raj 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.

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases