NCT01490463

Brief Summary

The purpose of this study is to determine the incidence and impact of brain lesions in MRI after coiling and clipping of unruptured intracranial aneurysms on clinical and neurological outcome of patients.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

December 12, 2011

Last Update Submit

January 28, 2013

Conditions

Unruptured Intracranial Aneurysms

Keywords

Treatment of

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with unruptured intracranial aneurysm undergoing endovascular or surgical treatment

You may qualify if:

  • diagnosis and treatment of unruptured intracranial aneurysm
  • age ≥ 18 yrs
  • written informed consent by patients prior to study participation
  • willingness to participate in follow-up

You may not qualify if:

  • ruptured intracranial aneurysm
  • contraindication for MRI
  • Participation in an intervention-/AMG-study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Goethe-University

Frankfurt am Main, Hesse, Germany

Location

Related Publications (1)

  • Platz J, Wagner M, Guresir E, You SJ, Konczalla J, de Rochemont RD, Berkefeld J, Seifert V. Early diffusion-weighted MRI lesions after treatment of unruptured intracranial aneurysms: a prospective study. J Neurosurg. 2017 Apr;126(4):1070-1078. doi: 10.3171/2016.2.JNS152456. Epub 2016 May 20.

    PMID: 27203140DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neurosurgery, Goethe-University Frankfurt am Main

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 13, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 30, 2013

Record last verified: 2013-01

Locations

DE(1)