The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

NCT06147102 | Active Not Recruiting

• 1 other identifier: HUS/216/2023
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm

Keywords

intracranial aneurysm; surgery; neurosurgery; endovascular; interventional neuroradiology; neurointervention; unruptured

Outcome Measures

Primary Outcomes (1)

• New ischemic lesion on postoperative MRI

  Diffusion-Weighted Imaging lesion

  1-3 days

Secondary Outcomes (8)

• Neurological symptom

  3 months

• Return to work

  3 months

• Functional outcome

  3 months

• Aneurysm occlusion on angiography

  6mo - 5yrs

• Patients with late rebleeding from the target aneurysm

  up to 10 yrs

Study Arms (2)

Endovascular treatment

Patients with unruptured intracranial aneurysms treated endovascularly

Procedure: Endovascular

Surgical treatment

Patients with unruptured intracranial aneurysms treated surgically

Procedure: Surgery

Interventions

Surgery PROCEDURE

Surgical treatment for the unruptured intracranial aneurysm

Surgical treatment

Endovascular PROCEDURE

Endovascular treatment for the unruptured intracranial aneurysm

Endovascular treatment

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients with an unruptured intracranial aneurysm undergoing treatment

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, 00029 HUS, Finland

Location

Related Publications (1)

• 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 5:1-10. doi: 10.3171/2025.7.JNS25775. Online ahead of print.

  PMID: 41349033 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rahul Raj, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 27, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

FI (1)