NCT05291637

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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
7 countries

22 active sites

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 5, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

March 4, 2022

Last Update Submit

June 3, 2024

Conditions

Stroke, Acute Ischemic

Keywords

Posterior occlusion artery (PCA)Intravenous thrombolysis (IVT)Endovascular therapy (EVT)Modified Rankin Scale (mRS)

Outcome Measures

Primary Outcomes (2)

  • Change in stroke outcome based on modified Rankin Scale (mRS)

    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.

    baseline, 90 days

  • Change in NIH Stroke Score (NIHSS)

    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.

    baseline, 7 days

Study Arms (2)

Medical management cohort

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

EVT management cohort

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

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients identified from electronic health records who have undergone stroke medical management treatment from 1/01/2003 to 01/01/2022 and patients who have undergone EVT stroke treatment from 01/01/2015 - 01/01/2022.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

University of Miami

Miami, Florida, 33124, United States

Location

Miami Baptist Health

Miami, Florida, 33176, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Cooper University Healthcare

Camden, New Jersey, 08103, United States

Location

University of Buffalo

Buffalo, New York, 14261, United States

Location

Mount Sinai Health

New York, New York, 10003, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

UT Texas Medical Center

Houston, Texas, 77030, United States

Location

Helsinki University Hospital

Helsinki, 00290, Finland

Location

Charite Berlin

Berlin, Germany

Location

Universitätsklinikum Knappschaftskrankenhaus Bochum

Bochum, Germany

Location

University Clinics Dresden

Dresden, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Heidelberg University

Heidelberg, 69117, Germany

Location

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, 47521, Italy

Location

Egas Moniz Hospital

Lisbon, 1349-019, Portugal

Location

Centro Hospitalar Universitário de Lisboa Central

Lisbon, Portugal

Location

Vall D'Hebron

Barcelona, Spain

Location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

University Hospital Basel

Basel, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 34393977BACKGROUND

  • 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.

    PMID: 35587104BACKGROUND

  • 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.

    PMID: 37222709RESULT

  • 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.

    PMID: 38753954RESULT

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Thanh N Nguyen, MD

    Boston Medical Center, Neurology

    PRINCIPAL INVESTIGATOR

  • Simon Nagel, MD

    Heidelberg University Hospital, Neurology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 22, 2022

Study Start

January 5, 2022

Primary Completion

May 31, 2022

Study Completion

January 31, 2023

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations

CH(2)ES(1)IT(1)FI(1)PT(2)DE(6)US(9)