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Completed

NCT Number: NCT04650022

Total Posterior-circulation Infarct Volume in Basilar Artery Stroke

Preprocedural predictors of outcome in patients with acute basilar artery occlusion (ABAO) who underwent endovascular treatment (EVT) remain controversial. The Investigators aimed to analyse, in patients with ABAO treated by EVT, if pre-EVT DWI total posterior-circulation infarct volume (TPIV) was a predictor of 90-days outcomes

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

Acute basilar artery occlusion (ABAO) is a rare and devastating type of stroke. Endovascular treatment (EVT) is routinely performed in real-world practice, encouraged by the recent result of the basilar artery international cooperation study (BASICS), a randomized controlled study.

ABAO may result in infarcts in the brainstem, cerebellar lobes, thalamus and subthalamic area, or occipitotemporal lobes. Previously, studies using the DWI Posterior-circulation Alberta Stroke Program Early CT (Pc-ASPECT) Score or brainstem score, for predicting outcome in patients with ABAO, showed that the initial infarct extend can affect outcome. Some of these studies included patients tretaed by EVT. But, results showed conflicting findings.

To date, evidence regarding the association between pre-ETVT DWI lesion volume and outcomes is relatively weak and has not yet be determined. Predictors of the outcomes of EVT for anterior circulation include infarcts volume. More recently, authors reported a predictive model of good outcome combining initial DWI infarct volume of less than 10 ml, onset-to-puncture time less than 8 hours and embolic origin in 71 Korean patients undergoing EVT for vertebrobasilar occlusion. Nevertheless, up now, there is not sufficient evidence to reach a consensus.

Using data of our prospective registry, the investigators analyzed consecutive MRI selected, endovascularly treated ABAO patients within the first 24h after symptom-onset. Using the initial Magnetic Resonance Imaging (MRI), baseline total posterior-Circulation infarct volume (TPCIV) was calculated in mL, on an apparent diffusion-coefficient map reconstruction (Olea sphere software).

TPCIV was analyzed in univariate and multivariable models as a predictor of 90-day functional independence (modified Rankin Scale [mRS] 0-2) and mortality. According to received operating characteristic (ROC) analysis, the optimal cut-off was determined by maximizing the Youden index, to evaluate the prognostic value of TPCIV.

The Investigators aimed to investigate the relationship between baseline DWI total TPCIV and the 90-days functional outcome and mortality, in a large cohort of ABAO selected by MRI prior to EVT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient with a clinical diagnosis of acute stroke in the posterior-circulation within 24 hours from symptom onset;
  • patient with a pertinent clinical deficit following physician evaluation (no NIHSS limit);
  • acute basilar ischemia assessed on MRI matching clinical symptoms and including DWI;
  • ABAO confirmed by intra-arterial arteriography and treated using mechanical thrombectomy.

Exclusion criteria

Patients were excluded if they were ineligible for an MRI or ineligible for MT for the following reasons:

  • prestroke modified Rankin Scale (mRS) score of >2;
  • life expectancy <3 months;
  • brainstem ischemia on DWI involving more than 80% of the area in axial view

Treatment and study plan

Mechanical Thrombectomy

Device

Stent retriever for treatment of cerebral arterial occlusions

Primary outcomes

  1. measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability

    Time frame: 90 day

    90-day functional outcome A favorable outcome was defined as a 90-day mRS≤2

Secondary outcomes

  1. Mortality rate

    Time frame: 90 day

    Mortality and the cause of death at 90 days

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Predicting Value of DWI Total Posterior-circulation Infarct Volume for Endovascular Treatment Outcomes of Acute Basilar Artery Occlusion

Acronym: TPCIV-ABAO

Important dates

Study start
2011
Primary completion
2018
Study completion
2019
First posted
Dec 2, 2020
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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