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NCT05729295
Cerebral Vascular Malformations: From Multimodal Imaging, to Endovascular, Surgical or Combined Treatment
trial testing Endovascular embolization or surgery in AVM (Arteriovenous Malformation) Intracranial in 200 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 24 June 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Endovascular embolization or surgery
Conditions studied
- AVM (Arteriovenous Malformation) Intracranial — all drugs for AVM (Arteriovenous Malformation) Intracranial →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with AVM (Arteriovenous Malformation) Intracranial. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05729295
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Endovascular embolization or surgery
Trials testing the same drug.
- NCT05713825 — Multidimensional Evaluation of Patients With Ruptured or Unruptured Cerebral Aneurysm Undergoing Endovascular or Surgica · unknown
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05729295 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 15 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05729295.
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