Multidimensional Evaluation of Patients With Ruptured or Unruptured Cerebral Aneurysm Undergoing Endovascular or Surgical Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Functional independence at 90 days assessed by Rankin scale (mRS).
Study Overview
Brief Summary
Cerebral aneurysms are common changes in intracranial angioarchitecture. Unruptured aneurysms are increasingly identified thanks to the imaging techniques used in daily clinical practice. Since bleeding remains a highly dramatic event burdened by significant morbidity-mortality (about 50%), endovascular therapy, in combination with classic surgical therapy, is an essential element in contemporary medicine.
Endovascular and surgical treatment represent the standard of care. The rationale of this study is to identify clinical and radiological characteristics, mainly neuro-radiological ones, not fully explored in previous studies, which can help predict the outcome of patients affected by cerebral aneurysm.
The study will have the characteristics of a retrospective study on patients with cerebral aneurysm treated at our center from 1 January 2015 to 31 December 2023.
Objective of the study is the multidimensional evaluation in patients with cerebral aneurysms, ruptured and unruptured, undergoing an endovascular embolization procedure or surgical treatment.
Detailed Description
Cerebral aneurysmal disease affects 2-5% of the world population, with 0.7-1.9% of cases of rupture resulting in subarachnoid hemorrhage (SAH). The most affected age group is wide - from 30 to 60 years - with a ratio between male and female gender equal to 1.6.
SAH accounts for approximately 5% of strokes and is burdened by high mortality and disability rates; in this particular situation, the patient is subjected in the shortest time possible to a clinical-anamnestic framework, to evaluate the severity of the clinical picture and quantify it through the use of the Hunt & Hess scale, which is followed by the direct tomographic examination, to evaluate the extent of the lesions.
Recently, numerous developments have been observed in the treatment, elective or acute, of cerebral aneurysm, such as the introduction of new therapeutic devices, such as the flow diversion stent or "flow diverter".
The primary objective of the treatment of a cerebral aneurysm must be different on the basis of the type of lesion and the patient's clinical conditions: while, in fact, the treatment of a ruptured aneurysm has the primary aim of avoiding immediate rebleeding and facilitating treatment intensive, the goal of treatment of an unruptured aneurysm must be the achievement of a stable result, up to and including exclusion from the circulation.
Endovascular therapy has reached such prominence that, in most teams, the right of first refusal in the treatment of aneurysmal subarachnoid hemorrhage rests with the interventional neuroradiologist and no longer with the neurosurgeon.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age > 18 years
- •ruptured or unruptured cerebral aneurysm with consistent neurologic and radiologic evidence.
- •CT without contrast medium and CT angiography, demonstrating the SAH and the aneurysm.
- •Execution of an endovascular embolization procedure (which is indicated by a neurosurgeon and interventional neuroradiologist) or surgical treatment.
Exclusion Criteria
- •non-aneurysmal causes of SAH (example: AVMs, AVDs and trauma).
Outcomes
Primary Outcomes
Functional independence at 90 days assessed by Rankin scale (mRS).
Time Frame: 90 days
A good clinical outcome will be defined as an modified Rankin Scale (mRS) score between 0 and 2 (mRS 0 identifies a patients with no symptoms, 6 identifies a dead patient).
Secondary Outcomes
- efficacy of endovascular treatment using the Raymond-Roy scale(at the end of the endovascular procedure)
- 90-day in-hospital mortality.(90 days)
- post-procedural symptomatic stroke/haemorrhage.(48 hours after the procedure)
Investigators
Alexandre Andrea, MD MSc
Principal Investigator, Neuroradiologist, MD MSc
Fondazione Policlinico Universitario Agostino Gemelli IRCCS