ClinicalTrials.gg
Status unknownNCT05729295Updated Feb 15, 2023

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

An observational study in AVM (Arteriovenous Malformation) Intracranial, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

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.

Numerous developments have been observed in the treatment, elective or acute, of AVMs and AVDs, ranging from neurosurgical intervention, endovascular embolization procedures using coils and adhesive and non-adhesive embolizing materials - even partial in view of a subsequent surgery - reaching to radiosurgical treatment (gamma-knife, cyber-knife and linear accelerator). Regardless of the type, the primary goal of treatment is healing, which occurs when the cerebral vascular malformation is permanently and persistently excluded from circulation.

Although clinical trials and meta-analyses have dispelled any doubts about the validity/necessity of the therapies, the authors are convinced that there may be some clinical and radiological characteristics, not fully explored in the aforementioned studies, which can help predict the outcome of such patients. The finding of these variables, if confirmed by subsequent trials aimed at the purpose, could in the future guide the selection of patients to undergo treatment as well as guide the choice of the best technique, endovascular or surgical in primis, to be applied according to the characteristics of each patient .

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.

02

Conditions studied

  • AVM (Arteriovenous Malformation) Intracranial
03

In context

Intracranial Arteriovenous Malformations

43 studies on the registry are indexed under Intracranial Arteriovenous Malformations; 15 are open to participants now.

This study's planned enrollment of 200 is above the median of 140 across 25 observational studies indexed under Intracranial Arteriovenous Malformations.

Browse Intracranial Arteriovenous Malformations studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • causes of haemorrhage other than cerebral vascular malformations (example: aneurysms and trauma).
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
200 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Interventions

  • ProcedureEndovascular embolization or surgery

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

06

What researchers measure

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).

    Time frame: 90 days clinical evaluation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 34910224 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2021 to primary completion in Dec 2021, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2023
First posted
Feb 15, 2023
StartActual
Jun 24, 2021
Primary completionActual
Dec 31, 2021
CompletionEst.
Dec 31, 2023
Last update
Feb 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05729295
Responsible party
Alexandre Andrea, MD MSc (MD, MSc, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Feb 15, 2023
Start date
Jun 24, 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2023 (estimated)
Last update
Feb 15, 2023

Study contacts

Andrea M Alexandre, MD, MSc
Contact
andrea.alexandre@policlinicogemelli.it
00390630151

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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