Posterior cerebraL ArTery Occlusion Study

NCT ID: NCT05291637

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-05

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Stroke, Acute Ischemic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Medical management cohort

Patients who have undergone medical management stroke treatment from 1/01/2003 to 01/01/2022; this could include intravenous thrombolysis.

No interventions assigned to this group

EVT management cohort

Patients who have undergone EVT stroke treatment from 01/01/2015 to 01/01/2022

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thanh N Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Neurology

Simon Nagel, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University Hospital, Neurology

Locations

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University of Miami

Miami, Florida, United States

Site Status

Miami Baptist Health

Miami, Florida, United States

Site Status

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Cooper University Healthcare

Camden, New Jersey, United States

Site Status

University of Buffalo

Buffalo, New York, United States

Site Status

Mount Sinai Health

New York, New York, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

UT Texas Medical Center

Houston, Texas, United States

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

Charite Berlin

Berlin, , Germany

Site Status

Universitätsklinikum Knappschaftskrankenhaus Bochum

Bochum, , Germany

Site Status

University Clinics Dresden

Dresden, , Germany

Site Status

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Heidelberg University

Heidelberg, , Germany

Site Status

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, , Italy

Site Status

Egas Moniz Hospital

Lisbon, , Portugal

Site Status

Centro Hospitalar Universitário de Lisboa Central

Lisbon, , Portugal

Site Status

Vall D'Hebron

Barcelona, , Spain

Site Status

Lausanne University Hospital

Lausanne, Canton of Vaud, Switzerland

Site Status

University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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United States Finland Germany Italy Portugal Spain Switzerland

References

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Herweh C, Abdalkader M, Nguyen TN, Puetz V, Schone D, Kaiser D, Chen CH, Jeng JS, Mohlenbruch MA, Ringleb PA, Nagel S. Mechanical Thrombectomy in Isolated Occlusion of the Proximal Posterior Cerebral Artery. Front Neurol. 2021 Jul 29;12:697348. doi: 10.3389/fneur.2021.697348. eCollection 2021.

Reference Type BACKGROUND
PMID: 34393977 (View on PubMed)

Berberich A, Finitsis S, Strambo D, Michel P, Herweh C, Meyer L, Hanning U, Strbian D, Abdalkader M, Nogueira RG, Puetz V, Kaiser DPO, Olive-Gadea M, Ribo M, Fragata I, Marto JP, Romoli M, Ringleb PA, Nguyen TN, Nagel S. Endovascular therapy versus no endovascular therapy in patients receiving best medical management for acute isolated occlusion of the posterior cerebral artery: A systematic review and meta-analysis. Eur J Neurol. 2022 Sep;29(9):2664-2673. doi: 10.1111/ene.15410. Epub 2022 Jun 17.

Reference Type BACKGROUND
PMID: 35587104 (View on PubMed)

Nguyen TN, Qureshi MM, Strambo D, Strbian D, Raty S, Herweh C, Abdalkader M, Olive-Gadea M, Ribo M, Psychogios M, Fischer U, Nguyen A, Kuramatsu JB, Haupenthal D, Kohrmann M, Deuschl C, Kuhne Escola J, Yaghi S, Shu L, Puetz V, Kaiser DPO, Kaesmacher J, Mujanovic A, Marterstock DC, Engelhorn T, Klein P, Haussen DC, Mohammaden MH, Abdelhamid H, Souza Viana L, Cunha B, Fragata I, Romoli M, Diana F, Virtanen P, Lappalainen K, Clark J, Matsoukas S, Fifi JT, Sheth SA, Salazar-Marioni S, Marto JP, Ramos JN, Miszczuk M, Riegler C, Jadhav AP, Desai SM, Maus V, Kaeder M, Siddiqui AH, Monteiro A, Masoud HE, Suryadevara N, Mokin M, Thanki S, Siegler JE, Khalife J, Linfante I, Dabus G, Asdaghi N, Saini V, Nolte CH, Siebert E, Meinel TR, Finitsis S, Mohlenbruch MA, Ringleb PA, Berberich A, Nogueira RG, Hanning U, Meyer L, Michel P, Nagel S. Endovascular Versus Medical Management of Posterior Cerebral Artery Occlusion Stroke: The PLATO Study. Stroke. 2023 Jul;54(7):1708-1717. doi: 10.1161/STROKEAHA.123.042674. Epub 2023 May 24.

Reference Type RESULT
PMID: 37222709 (View on PubMed)

Strambo D, Michel P, Nguyen TN, Abdalkader M, Qureshi MM, Strbian D, Herweh C, Mohlenbruch MA, Raty S, Olive-Gadea M, Ribo M, Psychogios M, Fischer U, Nguyen A, Kuramatsu JB, Haupenthal D, Kohrmann M, Deuschl C, Kuhne Escola J, Demeestere J, Lemmens R, Vandewalle L, Yaghi S, Shu L, Puetz V, Kaiser DPO, Kaesmacher J, Mujanovic A, Marterstock DC, Engelhorn T, Requena M, Dasenbrock HH, Klein P, Haussen DC, Mohammaden MH, Abdelhamid H, Souza Viana L, Cunha B, Fragata I, Romoli M, Diana F, Hu W, Zhang C, Virtanen P, Lauha R, Jesser J, Clark J, Matsoukas S, Fifi JT, Sheth SA, Salazar-Marioni S, Marto JP, Ramos JN, Miszczuk M, Riegler C, Poli S, Poli K, Jadhav AP, Desai SM, Maus V, Kaeder M, Siddiqui AH, Monteiro A, Masoud HE, Suryadareva N, Mokin M, Thanki S, Alpay K, Ylikotila P, Siegler JE, Linfante I, Dabus G, Asdaghi N, Saini V, Nolte CH, Siebert E, Serrallach BL, Weyland CS, Hanning U, Meyer L, Berberich A, Ringleb PA, Nogueira RG, Nagel S. Endovascular Versus Medical Therapy in Posterior Cerebral Artery Stroke: Role of Baseline NIHSS Score and Occlusion Site. Stroke. 2024 Jul;55(7):1787-1797. doi: 10.1161/STROKEAHA.124.047383. Epub 2024 May 16.

Reference Type RESULT
PMID: 38753954 (View on PubMed)

Related Links

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https://j-stroke.org/journal/view.php?number=533

Endovascular Thrombectomy Versus Intravenous Thrombolysis of Posterior Cerebral Artery Occlusion Stroke

Other Identifiers

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H-40712

Identifier Type: -

Identifier Source: org_study_id

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