Unruptured Intracranial AneurysmsLESUIANCT01490463
Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms
An observational study of Unruptured Intracranial Aneurysms, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unruptured Intracranial Aneurysms
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unruptured intracranial aneurysm undergoing endovascular or surgical treatment
Who may be able to join
- 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
Who cannot join
- ruptured intracranial aneurysm
- contraindication for MRI
- Participation in an intervention-/AMG-study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurosurgery, Goethe-University
Frankfurt am Main, Hesse
About this study
Official title: Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms: Incidence and Influence on Clinical Outcome in a Prospective Study.
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.
Read the 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.
- Conditions
- Unruptured Intracranial Aneurysms
- Keywords
- Treatment of
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Neurosurgery, Goethe-University Frankfurt am Main, Institute of Neuroradiology, Goethe-University Frankfurt am Main
- Responsible party
- Principal investigator, Erdem Güresir, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490463
- Sponsor's protocol ID
- JohannWGUH_LESUIA
- Acronym
- LESUIA
- Status last verified
- Jan 2013
- First submitted
- 12 Dec 2011
- Last updated
- 30 Jan 2013
- Results posted
- No
Publications
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.
PubMed 27203140
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms: Incidence and Influence on Clinical Outcome in a Prospective Study.
- ClinicalTrials.gov ID
- NCT01490463
- Acronym / sponsor ID
- LESUIA / JohannWGUH_LESUIA
- Conditions
- Unruptured Intracranial Aneurysms
- Keywords
- Treatment of
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Department of Neurosurgery, Goethe-University Frankfurt am Main, Institute of Neuroradiology, Goethe-University Frankfurt am Main
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unruptured intracranial aneurysm undergoing endovascular or surgical treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- ruptured intracranial aneurysm
- contraindication for MRI
- Participation in an intervention-/AMG-study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
- Derived from this study: PubMed 27203140Platz 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.
Related trials for Unruptured Intracranial Aneurysms
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
RecruitingObservational study
Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
Intracranial Sacciform Aneurysm
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
RecruitingObservational study
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unruptured Intracranial Aneurysms, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01490463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.