This Three-year Observational Study Involves Patients of All Ages Undergoing Endovascular Treatment for Various Cerebral or Spinal Vascular Conditions. It Aims to Assess Pre- and Post-operative Clinical Conditions, Report Complications, and Identify Preoperative Indicators of Treatment Outcomes. Pat
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Aneurysm Cerebral, AVM, DAFV, ESDC. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
OUTCOME IN NEURORADIOLOGIA INTERVENTISTICA INDICAZIONI COMPLICANZE (ONIRIC)
Overview
This three-year observational study involves patients of all ages undergoing endovascular treatment for various cerebral or spinal vascular conditions. It aims to assess pre- and post-operative clinical conditions, report complications, and identify preoperative indicators of treatment outcomes. Patients will also receive psychological support and Neuropsychological assessment. Clinical, medical, and demographic data will be recorded in a database during hospitalization and follow-up visits.
Primary outcome measures
- Safety and Efficacy of the Endovascular procedures [Time frame: 1 year after treatment]
- Landriel-Ibanez Scale [Time frame: 1 year after treatment]
- National Institutes of Health Stroke Scale (NIHSS) [Time frame: 1 year after treatment]
- Modified Rankin Scale (mRS) [Time frame: 1 year after treatment]
- Aminoff-Loug Scale [Time frame: 1 year after treatment]
- Neursopychological status and Quality of life: [Time frame: 1 year after treatment]
- World Health Organization Disability Assessment Schedule (WHODAS): [Time frame: 1 year after treatment]
- EQ-5D-5L [Time frame: 1 year after treatment]
- State and Traits Anxiety Inventory (STAI) [Time frame: 1 year after treatment]
- Beck Depression Inventory (BDI-II) [Time frame: 1 year after treatment]
Secondary outcome measures (7)
- Preprocedural outcome identification [Time frame: pre-procedure]
- Socio-demographic variables [Time frame: pre-procedure]
- Comorbidities [Time frame: pre-procedure]
- Pre-procedure medical treatment [Time frame: pre-procedure]
- Morphology of the endovascular pathology [Time frame: pre-procedure]
- Dimension in mm [Time frame: pre-procedure]
- Location [Time frame: pre-procedure]
Eligibility criteria
Inclusion criteria
- Patients of both sexes and any age, who are referred to the Department of Neurosurgery and Clinical Neurosciences and are candidates for interventional endovascular procedures for any cerebral or spinal pathology, will be included in the study.
Exclusion criteria
- /
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Foundation IRCCS Carlo Besta Neurological Institute — Milan
Identifiers
NCT: NCT06805721 · ONIRIC