Posterior cerebraL ArTery Occlusion Study

Completed

• Conditions: Stroke, Acute Ischemic

• Registration Number: NCT05291637
• Lead Sponsor: Boston Medical Center

Brief Summary

For this retrospective study, the investigators will collect and analyze data of patients who presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular stroke treatment).

The electronic health records will be queried for the demographic, medical history, and outcomes data of all patients with posterior cerebral artery occlusion who underwent mechanical thrombectomy, intravenous thrombolysis (IVT), or medical management.

Detailed Description

The primary aims of the research are to evaluate, in patients presenting with posterior artery occlusion (PCA), whether favorable outcome would be superior for EVT compared to Medically Management (MM), inclusive of intravenous thrombolysis (IVT), as measured by:

* 90-day modified Rankin Scale (mRS) ordinal shift or

* decrease in NIH Stroke Scale/Score (NIHSS) by two points at 24 hours or at hospital discharge

The secondary aims are to evaluate in patients presenting with PCA occlusion, other outcome and safety metrics:

* 90-day functional independence, mRS 0-2

* 90-day excellent outcome, mRS 0-1

* Visual field recovery (none, partial, complete) by 90-days

* rate of reperfusion by modified thrombolysis in cerebral infarction (TICI) scale grade

* any intracranial hemorrhage

* symptomatic intracranial hemorrhage

* mortality

In subgroup analysis, the investigators aim to identify subgroups that may confer differential treatment benefit by:

* location of occlusion on the PCA segment (P1, P2, P3)

* NIHSS strata (0-6, 7-15,\>16)

* time from symptom onset to treatment (0 to \<6h vs 6-24h)

* posterior circulation (PC) Acute Stroke Prognosis Early Computed Tomography Score (ASPECTS)

* visual field defect on presentation

The investigators hypothesize that greater benefit in outcomes would be seen in EVT treated patients with higher NIHSS, more proximal PCA occlusion, higher PC ASPECTS scores, and shorter time from symptom onset to treatment.

Study Timeline

• Study Start: 2022-01-05
• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-13
• Study First Posted: 2022-03-22
• Primary Completion: 2022-05-31
• Study Completion: 2023-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1282

Inclusion Criteria

• Had an ischemic stroke with isolated posterior cerebral artery occlusion (P1, P2, or P3 segments) and was medically managed or managed with EVT during the study time period.

Exclusion Criteria

• Patient with documented basilar artery occlusion and concomitant PCA occlusion
• Patient with documented basilar artery occlusion, migration with secondary PCA occlusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in stroke outcome based on modified Rankin Scale (mRS)	baseline, 90 days	The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. Scores can range from 0-6, where 0 is no disability, 5 is disability requiring constant care for all needs, and 6 is death. For this outcome an ordinal shift analysis will be done, assessing all changes across the range from baseline at 90 days.
Change in NIH Stroke Score (NIHSS)	baseline, 7 days	The NIH Stroke Scale/Score (NIHSS) is is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Scores can range from 0 to 42 and higher scores are associated with more severe stroke: 1-4= Minor stroke, 5-15= Moderate stroke, 15-20= Moderate/severe stroke, and 21-42 =Severe stroke.

Trial Locations

Locations (22)

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Lausanne University Hospital; 🇨🇭 Lausanne, Vaud, Switzerland

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Heidelberg University; 🇩🇪 Heidelberg, Germany

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

University of Miami; 🇺🇸 Miami, Florida, United States

Centro Hospitalar Universitário de Lisboa Central; 🇵🇹 Lisbon, Portugal

Vall D'Hebron; 🇪🇸 Barcelona, Spain

IRCCS Istituto delle Scienze Neurologiche di Bologna; 🇮🇹 Bologna, Italy

Charite Berlin; 🇩🇪 Berlin, Germany

University Hospital Basel; 🇨🇭 Basel, Switzerland

Miami Baptist Health; 🇺🇸 Miami, Florida, United States

Mount Sinai Health; 🇺🇸 New York, New York, United States

Cooper University Healthcare; 🇺🇸 Camden, New Jersey, United States

University of Buffalo; 🇺🇸 Buffalo, New York, United States

UT Texas Medical Center; 🇺🇸 Houston, Texas, United States

University Clinics Dresden; 🇩🇪 Dresden, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Egas Moniz Hospital; 🇵🇹 Lisboa, Portugal

Universitätsklinikum Knappschaftskrankenhaus Bochum; 🇩🇪 Bochum, Germany