Cerebral Vascular Malformations: From Multimodal Imaging, to Endovascular, Surgical or Combined Treatment

NCT05729295 | Unknown

• 1 other identifier: 3957
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebrovascular malformations (CVMs) are a heterogeneous group of disorders and can be classified histopathologically into five main categories: arteriovenous malformations (AVMs), dural arteriovenous fistulas (AVDs), abnormalities of venous development or venous angiomas (VAS), cavernous malformations (CVMs), ) and capillary telangiectasis (TAC). A further classification, more useful from a therapeutic point of view, is the functional one, which provides for a subdivision into two categories: CVD with arteriovenous shunt - among which AVMs and AVD stand out - and CVD without arteriovenous shunt. AVMs and AVDs represent the two cerebrovascular malformations of greatest interest in the field of interventional neuroradiology. AVMs generally have a congenital origin, an estimated prevalence in the population of 0.005-0.6% and are most commonly diagnosed between the ages of 20 and 40, with an estimated annual bleeding risk between 4% and 4%; AVDs are rarer and have a predominantly acquired origin, in relation to previous thrombosis and trauma. Intra- and extra-parenchymal hemorrhages are a frequent finding of cerebral vascular malformations, associated or not with headache, epileptic seizures or focal neurological deficits (from mass effect or vascular steal, with consequent ischemia); in this particular situation, the patient is subjected in the shortest possible time to a clinical-anamnestic assessment, to evaluate the severity of the clinical picture, which is followed by a tomographic examination to evaluate the extent of the lesions and classify the malformation- classification of Spetzler-Martin for AVMs and Cognard or Borden classification for AVDs. Therefore, it is the authors' intention to conduct a retrospective and prospective observational study with the aim of exploring the possible implication of new variables that can predict with sufficient accuracy the outcome of patients with ruptured and unruptured cerebral vascular malformations; a possible positive response could be followed by a more structured clinical trial with which to derive the appropriate conclusions with greater methodological soundness.

Conditions

AVM (Arteriovenous Malformation) Intracranial

Outcome Measures

Primary Outcomes (1)

• Functional Independence

  Functional independence at 90 days assessed by modified Rankin scale (mRS). A good clinical outcome will be defined as an mRS score between 0 and 2 (as per the literature).

  90 days clinical evaluation

Interventions

Endovascular embolization or surgery PROCEDURE

Endovascular embolization with embolizing agents (including glue, non-adhesive agents) or neurosurgical excision of the lesion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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=200 patients is proposed.

You may qualify if:

• age \> 18 years
• unruptured and ruptured cerebral vascular malformation with consistent neurologic and radiologic evidence.
• Performing CT without contrast medium and CT angiography.
• Execution of an endovascular embolization procedure (which is indicated by a neurosurgeon and interventional neuroradiologist) or surgical treatment.

You may not qualify if:

• \- causes of haemorrhage other than cerebral vascular malformations (example: aneurysms 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

Related Publications (1)

• Alexandre AM, Sturiale CL, Bartolo A, Romi A, Scerrati A, Flacco ME, D'Argento F, Scarcia L, Garignano G, Valente I, Lozupone E, Pedicelli A. Endovascular Treatment of Cavernous Sinus Dural Arteriovenous Fistulas. Institutional Series, Systematic Review and Meta-Analysis. Clin Neuroradiol. 2022 Sep;32(3):761-771. doi: 10.1007/s00062-021-01107-0. Epub 2021 Dec 15.

  PMID: 34910224 BACKGROUND

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: June 24, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)