Brain Lesions Following Endovascular and Surgical Treatme... | NCT01490463

Studies
Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms

NCT01490463

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Jan 30, 2013Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Unruptured Intracranial Aneurysms

Interventions

Not provided

Countries

Germany

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Dec 12, 2011

First Submission Date that Met QC Criteria

Dec 12, 2011

First Posted Date

Dec 13, 2011Estimated

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

Jan 28, 2013

Last Update Posted Date

Jan 30, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erdem Güresir, Department of Neurosurgery, Goethe-University Frankfurt am Main, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Name	Class
Department of Neurosurgery, Goethe-University Frankfurt am Main	UNKNOWN
Institute of Neuroradiology, Goethe-University Frankfurt am Main	UNKNOWN

Description Module

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.

Detailed Description

Silent ischemic lesions after treatment of unruptured intracranial aneurysm (UIA) might alter patients' clinical and neurological outcome. Furthermore silent brain lesions are not well documented after endovascular and surgical treatment of unruptured intracranial aneurysms. Therefore, the investigators investigate the incidence and influence of treatment-related ischemic lesions in magnetic resonance / diffusion-weighted-imaging after endovascular and surgical treatment of UIA.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with unruptured intracranial aneurysm undergoing endovascular or surgical treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery, Goethe-University		Frankfurt am Main	Hesse		Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27203140	Derived	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.