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Stroke, Acute IschemicPLATONCT05291637

Posterior cerebraL ArTery Occlusion Study

An observational study of Stroke, Acute Ischemic, run by Boston Medical Center at 22 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Stroke, Acute Ischemic
Type of treatment
Injection or infusion
How many people
1,282 participants
Where
22 sitesin 7 countries
Study dates
5 Jan 2022to 31 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

22 sites in 7 countries.

22 sites in 7 countries

United States9 sites
  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • University of Buffalo

    Buffalo, New York, 14261

  • Cooper University Healthcare

    Camden, New Jersey, 08103

  • UT Texas Medical Center

    Houston, Texas, 77030

  • University of Miami

    Miami, Florida, 33124

  • Miami Baptist Health

    Miami, Florida, 33176

  • Mount Sinai Health

    New York, New York, 10003

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261

Other trials in United States

Germany6 sites
  • Charite Berlin

    Berlin

  • Universitätsklinikum Knappschaftskrankenhaus Bochum

    Bochum

  • University Clinics Dresden

    Dresden

  • Universitätsklinikum Erlangen

    Erlangen

  • University Medical Center Hamburg-Eppendorf

    Hamburg

  • Heidelberg University

    Heidelberg, 69117

Other trials in Germany

Portugal2 sites
  • Egas Moniz Hospital

    Lisbon, 1349-019

  • Centro Hospitalar Universitário de Lisboa Central

    Lisbon

Other trials in Portugal

Switzerland2 sites
  • University Hospital Basel

    Basel

  • Lausanne University Hospital

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

Finland1 site
  • Helsinki University Hospital

    Helsinki, 00290

Other trials in Finland

Italy1 site
  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    Bologna, 47521

Other trials in Italy

Spain1 site
  • Vall D'Hebron

    Barcelona

Other trials in Spain

About this study

Official title: Endovascular Therapy vs Medical Management of PosterIor Cerebral Artery Occlusion Stroke

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.

Read the 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.

Keywords
Posterior occlusion artery (PCA), Intravenous thrombolysis (IVT), Endovascular therapy (EVT), Modified Rankin Scale (mRS)
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05291637
Study groupRoleWhat they receive
Medical management cohortPatients who have undergone medical management stroke treatment from 1/01/2003 to 01/01/2022; this could include intravenous thrombolysis.
EVT management cohortPatients who have undergone EVT stroke treatment from 01/01/2015 to 01/01/2022

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, 90 days

  2. 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.

    Measured: baseline, 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2022
  2. Study start5 Jan 2022
  3. Primary completion31 May 2022
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05291637
Sponsor's protocol ID
H-40712
Acronym
PLATO
Status last verified
Jun 2024
First submitted
4 Mar 2022
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34393977
  • 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.

    PubMed 35587104
  • 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.

    PubMed 37222709
  • 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.

    PubMed 38753954
  • Diel NJ, Strambo D, Abdalkader M, Qureshi MM, Dunet V, Bartolini B, Pistocchi S, Strbian D, Raty S, Herweh C, Mohlenbruch M, 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, Yedavalli V, Maroufi SF, Puetz V, Kaiser DPO, Kaesmacher J, Mujanovic A, Marterstock DC, Engelhorn T, Requena M, Klein P, Doan B, Jorda-Baleri T, Haussen DC, Mohammaden MH, Abdelhamid H, Souza Viana L, Cunha B, Fragata I, Romoli M, Ruggiero M, Diana F, Hu W, Zhang C, Virtanen P, Lauha R, Matsoukas S, Fifi JT, Sheth SA, Salazar-Marioni SA, Marto JP, Ramos JN, Miszczuk M, Riegler C, Poli S, Poli K, Scarcia L, Jadhav AP, Maus V, Aust A, Yapici F, Siddiqui AH, Monteiro A, Jaikumar V, Masoud HE, Begum M, 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, Meyer L, Berberich A, Ringleb PA, Nogueira RG, Michel P, Nagel S, Nguyen TN. Role of Perfusion Parameters on Outcomes and Safety of Endovascular Therapy in Posterior Cerebral Artery Stroke. Stroke. 2026 Sep;57(9):2661-2676. doi: 10.1161/STROKEAHA.126.055949. Epub 2026 Jul 9.

    PubMed 42422957

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Acute Ischemic, run by Boston Medical Center at 22 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Germany, Portugal, Switzerland, Finland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in stroke outcome based on modified Rankin Scale (mRS) (time frame: baseline, 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05291637, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024; AzTrials last refreshed its copy on 29 Oct 2026.

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