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

NCT06805721 | Recruiting

• 1 other identifier: ONIRIC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aneurysm Cerebral; AVM; DAFV; ESDC

Keywords

Endovascular treatment; Neurospychological assessment; Aneurysm; AVM; Psychological Outcome

Outcome Measures

Primary Outcomes (21)

• Safety and Efficacy of the Endovascular procedures

  Describe the safety and efficacy of endovascular procedures performed for cerebro-spinal vascular diseases or hypervascularized lesions treated in the institute either through endovascular means or direct puncture. In order to the describe safety and efficay, the analysis will report the number and the nature of clinical and technical adverse events related or unrelated to a device deficiency, as assessed by CTCAE v4.0. Moreover ther will be a qualitative and quantitive (Landriel-Ibanez scale) report of the complications, and the clinical outcomes (NIHSS, mRS, Aminoff-Loug scale).

  1 year after treatment

• Landriel-Ibanez Scale

  Assesses functional outcome and recovery in patients, often after neurological injuries or interventions. Scores range from 0 to 4: 0 indicates no deficits, while higher scores indicate worse functional outcomes or greater levels of disability.

  1 year after treatment

• National Institutes of Health Stroke Scale (NIHSS)

  Quantifies the severity of neurological impairment in stroke patients, focusing on motor, sensory, language, and visual deficits. Scores range from 0 to 42: 0 indicates no neurological deficits, Scores 1-4 Minor stroke, Scores 5-15 Moderate stroke, Scores 16-20 Moderate-to-severe stroke, Scores 21-42 Severe stroke. Higher scores indicate greater stroke severity.

  1 year after treatment

• Modified Rankin Scale (mRS)

  Assesses the degree of disability or dependence in daily activities after a stroke or other neurological conditions. Scores range from 0 to 6, with higher scores indicate worse outcomes or greater levels of disability.

  1 year after treatment

• Aminoff-Loug Scale

  Evaluates functional impairments. It focuses on mobility and dependency in activities of daily living. Scores range from 0 to 5 with higher scores reflecting increasing disability and dependence in daily living activities.

  1 year after treatment

• Neursopychological status and Quality of life:

  Describe the neuropsychological status and quality of life of the patient before and after (3month/6month Follow-Up and 1 year Follow-Up) the execution of such procedures. The goal is to better understand if there will be a significative change regarding such variables. The questionnaire and tests used for such assessment are listed below.

  1 year after treatment

• World Health Organization Disability Assessment Schedule (WHODAS):

  Assesses disability and impairment in various life domains, with score ranging fro 0 to 100, where higher scores indicate higher disability. This scale will be part of the quality of life assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• EQ-5D-5L

  Assesses health-related quality of life across five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each domain has a score range fro 1 to five, where higher scores reflect lower quality of life. The VAS (Visual Analogue Scale) can be used as a quantitative measure of health outcome that reflects the patient's own judgement, with a score range from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine"). This scale will be part of the quality of life assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• State and Traits Anxiety Inventory (STAI)

  Assesses anxiety in two dimensions: state anxiety (temporary and situation-specific) and trait anxiety (a stable characteristic). Each dimension ranges from 20 to 80, with Higher scores indicate higher levels of anxiety. This scale will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• Beck Depression Inventory (BDI-II)

  Evaluates the severity of depressive symptoms. Score ranges from 0 to 63, higher scores indicate more severe depression. This scale will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• Coping Orientation to Problems Experienced Inventory (Brief-COPE)

  Evaluates coping strategies in response to stress. Each subscale ranges from 2 to 8, with different strategies assessed (e.g., active coping, avoidance), Scores indicate the extent to which specific coping strategies are used, with no direct "better" or "worse. This scale will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• Mini Mental State Examination (MMSE)

  Assessing generic cognitive function. Raw scores range from 0 to 30, according to Maesso 1993 and Magni 1996, with higher scores indicating better cognitive fuctioning. The raw score are corrected by age and educationT This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• Raven Progressive Matrices (RPM)

  Assees Nonverbal reasoning and problem-solving abilities. Raw Scores, according to the version of Carlesimo et. Al. 1995, range from 0 to 36, then corrected by eduction and age and converted toequivalent scores. Higher scores means better perfomance. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• Ray Auditory Verbal Learning Test (RAVLT)

  Assesses verbal learning and memory. Higher scores indicate better memory performance, with lerning scores range fro 0 to 75 and log term memory from 0 to 15. Raw scores, according to the version of Carlesimo et. Al. 1996, are then corrected by age and education and converted into equivalent scores. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• Rey-Osterrieth Complex Figure (ROCF)

  Assesses visuospatial ability, memory, and planning through figure reproduction and recall. Raw scores range from 0 to 36 for both reproduction and recall and, according to the version of Caffarra et. Al. 2002, are then corrected by education and age and converted to equivalent scores. Higher scores indicate better visuospatial and memory performance. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• Trail Making Test - A and B (TMT-A-B)

  Measures visual attention, task-switching, and processing speed (TMT-A: sequencing numbers; TMT-B: alternating between numbers and letters). The score is determined by the time used to complete the tasks, the higher it is the poorer is the performance. Raw time scores are then corrected by age and education and then converted into equivalent scores, according to the version of Giovagnoli et al.1996. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• F-A-S Phonemic Verbal Fluency Test

  Assesses verbal fluency by generating words starting with specific letters (e.g., F, A, S) within 60 seconds. The higher is the number of words produced, the higher the performance. The raw score is then corrected by age and education and then converted into equivalent scores, according to the version of Carlesimo et al. 1995. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• Category Verbal Fluency Test

  Assesses semantic verbal fluency by generating words within specific categories (e.g., animals) in 60 seconds. The higher is the number of words produced, the higher the performance. The raw score, the number of words produced in the set time, is then corrected by age and education and then converted into equivalent scores, according to the version of Carlesimo et al. 1995. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

  1 year after treatment

• Verbal Digit Span

  Assesses short term memoty (forward) and workin memory (backward). The score is determined by the amount of numers that the patiente reports correctly (span). The raw score is then corrected by age and education and then converted into equivalent scores, according to the version of Monaco et al. 2012.

  1 year after treatment

• Frontal Assessment Battery (FAB)

  Assesses various executive function (Conceptualization, Mental flexibility, Motor programming, Sensitivity to interference, Inhibitory control and environmental autonomy). For each dimension the score range is from 0 to 3, resulting in a total score of 18. The raw score is then corrected by age and education and then converted into equivalent scores, according to the version of Apollnio et al. 2005.

  1 year after treatment

• Stroop Test

  The test consist of three different parts (words, color and word-color) and assesses processing speed, attention and inhibitory control. The performance is determined by time and errrors in completing the task. Both time and errors raw scores, after being processed through the dedicated formula, are then corrected by age and education and the converted in equivalent scores, according to Cafarra et al. 2002.

  1 year after treatment

Secondary Outcomes (7)

• Preprocedural outcome identification

  pre-procedure

• Socio-demographic variables

  pre-procedure

• Comorbidities

  pre-procedure

• Pre-procedure medical treatment

  pre-procedure

• Morphology of the endovascular pathology

  pre-procedure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients of both sexes and any age who will undergo endovascular treatment and who have signed the specific consent form for participation in the study.

You may qualify if:

• 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.

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Foundation IRCCS Carlo Besta Neurological Institute

Milan, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Elisa Ciceri, M.D.

CONTACT

02.2394.2411-2412; elisa.ciceri@istituto-besta.it

Matteo Milani, M.D.

CONTACT

02.2394.2411-2412; matteo.milani@istituto-besta.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 3, 2025
• Study Start: February 6, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)