NCT05029947

Brief Summary

To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following microsurgical clipping of unruptured intracranial aneurysms (UIA).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

August 29, 2021

Last Update Submit

September 21, 2022

Conditions

AneurysmAneurysm, BrainAneurysm CerebralAneurysm of Cerebral ArteryAneurysm, Intracranial

Outcome Measures

Primary Outcomes (3)

  • Complete occlusion of aneurysm

    Aneurysm remnant in CT scan or angiography

    up to 6 months

  • Retreatment of aneurysm

    Necessity of retreatment in endovascular or microsurgical technique

    up to 6 months

  • Mortality

    Death of the patient

    up to 6 months

Secondary Outcomes (7)

  • Chronic subdural hematoma

    up to 6 months

  • Stroke

    up to 6 months

  • Cerebral vasospasm

    up to 6 months

  • Intracerebal haemorrhage

    up to 6 months

  • New neurological deficit

    up to 6 months

  • +2 more secondary outcomes

Interventions

Microsurgical Clipping of Unruptured Intracranial AneurysmPROCEDURE

Microsurgical Clipping of Unruptured Intracranial Aneurysm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm

You may qualify if:

  • Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm
  • High-volume centers with ≥40 cases per year during the study period

You may not qualify if:

  • Treatment following subarachnoid haemorrhage
  • Clipping following an incomplete occlusion after previous treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

AneurysmIntracranial Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Lasse Dührsen, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Drexler, MD

CONTACT

004915222816461r.drexler@uke.de

Lasse Dührsen, MD

CONTACT

l.duehrsen@uke.de

Study Design

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

Study Record Dates

First Submitted

August 29, 2021

First Posted

September 1, 2021

Study Start

January 1, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations

DE(1)