Multidimensional Evaluation of Patients With Ruptured or Unruptured Cerebral Aneurysm Undergoing Endovascular or Surgical Treatment

NCT05713825 | Unknown

• 1 other identifier: 3583
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

• Functional independence at 90 days assessed by Rankin scale (mRS).

  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).

  90 days

Secondary Outcomes (3)

• 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

Interventions

Endovascular embolization or surgery PROCEDURE

* Endovascular embolization may be done with coils, remodeling technique (coils and balloon), stent and coils, flow-diverter, endosaccular devices. The access is through the femoral or radial artery. * Surgery is considered the standard neurosurgical procedure of aneurysm clipping.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Given the purely descriptive nature of the primary objective, we do not proceed with the formal calculation of the sample size but a sample of N=500 patients is proposed.

You may qualify if:

• 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.

You may not qualify if:

• non-aneurysmal causes of SAH (example: AVMs, AVDs and trauma).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Andrea M Alexandre, MD, MSc

CONTACT

00390630151; andrea.alexandre@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neuroradiologist, MD MSc

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: January 31, 2023
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)