NCT04611178

Brief Summary

Preprocedural predictors of outcome in patients with acute basilar artery occlusion (ABAO) who underwent endovascular treatment (EVT) remain controversial. Our aim was to analyze if pre-EVT diffusion-weighted images cerebellar infarct volume (CIV) was a predictor of 90-day outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2011

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

7.7 years

First QC Date

October 26, 2020

Last Update Submit

November 6, 2020

Conditions

Ischemic Stroke

Keywords

MRIPosterior fossaThrombectomyStroke

Outcome Measures

Primary Outcomes (1)

  • Rate of Functional outcome at 90-day

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

    90 day

Secondary Outcomes (1)

  • Mortality rate

    90 day

Study Arms (1)

CIV-ABAO

CIV-ABAO

Device: Mechanical thrombectomy

Interventions

Mechanical thrombectomyDEVICE

Stent retriever for treatment of cerebral arterial occlusions

CIV-ABAO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients \>18 years, referred to our hospital, from January 2011 to October 2018, presenting acute basilar artery occlusion (ABAO) confirmed by magnetic resonance imaging treated by endovascular thrombectomy, with or without intravenous thrombolysis.

You may qualify if:

  • 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; and
  • ABAO confirmed by intra-arterial arteriography and treated using mechanical thrombectomy.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Isabelle Mourand, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 2, 2020

Study Start

January 30, 2011

Primary Completion

October 1, 2018

Study Completion

January 1, 2019

Last Updated

November 10, 2020

Record last verified: 2020-10

Locations

FR(1)