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EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum VeSsel Occlusion sTroke

NCT ID: NCT05029414

Last Updated: 2024-12-24

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2025-06-01

Brief Summary

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Acute ischemic stroke (AIS) is one of the main causes of disability and loss of quality adjusted life years. This study is to analyze whether endovascular therapy (EVT) in addition to best medical treatment (BMT) reduces the degree of disability and dependency in daily activities after a Medium Vessel Occlusion (MeVO) stroke compared to BMT alone.

Detailed Description

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Acute ischemic stroke (AIS) is one of the main causes of death and disability and thereby the third leading cause of loss of quality adjusted life years. For patients with an AIS due to an occlusion of the large vessels of the anterior circulation, endovascular therapy (EVT) has become a treatment standard. 20-40% of all AIS patients have occlusions of smaller vessels and present with a more distal isolated Medium Vessel Occlusion (MeVO). The primary objective of this randomized trial is to determine whether patients experiencing an AIS due to an isolated medium vessel occlusion have superior functional outcome (measured with the Modified Rankin Scale "mRS" at 90 days) when treated with EVT plus best medical treatment (BMT) compared to patients treated with BMT alone. In this trial, all commercially available, CE-certified revascularisation devices (i.e. stent-retriever, aspiration catheters and balloon guide catheters) can be used for EVT. All established techniques for the endovascular treatment of AIS patients are permitted and all decisions regarding treatment technique and choice of devices and/or medications are made solely by the treating physician.

Conditions

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Acute Ischemic Stroke

Keywords

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Stroke Medium Vessel Occlusion Endovascular Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic, parallel group, randomized, open label, superiority trial with blinded endpoint assessment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
A treatment-blinded person will assess the primary outcome dependency and disability in everyday life (measured with the modified Rankin Scale (mRS)) at 90 days. All interviewers will be certified for the conductance of mRS.

interviews.

Study Groups

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Intervention group: EVT + BMT

Patients randomized to the EVT arm will undergo endovascular therapy (EVT) in addition to best medical treatment (BMT). All decisions regarding EVT device and EVT technique will be made by the treating physician.

Group Type EXPERIMENTAL

Endovascular Therapy

Intervention Type PROCEDURE

Endovascular treatment of stroke is the non-surgical treatment for the sudden loss of brain function due to blood clots. The blood clot is removed from the blood via devices (i.e. stent-retriever, aspiration catheters and balloon guide) to achieve revascularization.

Control group: BMT

Patients randomized to the control arm will NOT undergo EVT but will get best medical treatment (BMT) including intravenous thrombolysis (IVT) or antiplatelet therapy if indicated under current international guidelines and according to routine clinical practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endovascular Therapy

Endovascular treatment of stroke is the non-surgical treatment for the sudden loss of brain function due to blood clots. The blood clot is removed from the blood via devices (i.e. stent-retriever, aspiration catheters and balloon guide) to achieve revascularization.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Acute ischemic stroke
* Treatment (arterial puncture) can be initiated 2.1. Within 6 hours of last seen well (LSW) OR 2.2. Within 6 to 24 hours of LSW AND
* CT Criteria: Evidence of a hypoperfusion-hypodensity mismatch (Absence of hypodensity on the noncontrast CT within ≥ 90% of the area of the hypoperfused lesion on perfusion CT)
* MRI Criteria: Evidence of a diffusion-hyperintensity mismatch (Absence of hyperintensity on fluid-attenuated inversion recovery (FLAIR) imaging within ≥ 90% of the area of the diffusion weighted imaging(DWI) lesion)
* Isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant M2, the M3/M4 segment of theMCA, the A1/A2/A3 segment of the ACA or the P1/P2/P3 segment of the PCA) confirmed by CT or MRIAngiography
* National Institute of Health Stroke Scale (NIHSS) Score of ≥ 4 points or symptoms deemed clearly disabling by treating physician (i.e. aphasia, hemianopia, etc.)
* Informed Consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent
* Agreement of treating physician to perform endovascular procedure

Exclusion Criteria

* Acute intracranial haemorrhage
* Patient bedridden or presenting from a nursing home
* In-Hospital Stroke
* Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys
* Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
* Pregnancy or lactating women. A negative pregnancy test before randomisation is required for all women with child-bearing potential.
* Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the arterial access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after EVT
* Severe comorbidities, which will likely prevent improvement or follow-up
* Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma)
* Radiological confirmed evidence of cerebral vasculitis
* Evidence of vessel recanalization prior to randomisation
* Participation in another interventional trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Fund for Scientific Research

OTHER

Sponsor Role collaborator

Stryker Neurovascular

INDUSTRY

Sponsor Role collaborator

Penumbra Inc.

INDUSTRY

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

Phenox GmbH

INDUSTRY

Sponsor Role collaborator

Rapid Medical

INDUSTRY

Sponsor Role collaborator

Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marios-Nikos Psychogios, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Interventional and Diagnostical Neuroradiology, University Hospital Basel

Urs Fischer, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Neurology, Inselspital, Bern University Hospital

Locations

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AZ Sint-Jan Brugge

Bruges, , Belgium

Site Status

Hôpital Civil Marie Curie Charleroi

Charleroi, , Belgium

Site Status

UZ Universiteit Gent

Ghent, , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

Site Status

Universitair Ziekenhuis Leuven

Leuven, , Belgium

Site Status

Clinique CHC MontLégia

Liège, , Belgium

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

Uniklinik RHTW Aachen

Aachen, , Germany

Site Status

Charité-Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Klinikum Bremen-Mitte

Bremen, , Germany

Site Status

Uniklinikum Dresden

Dresden, , Germany

Site Status

Helios Klinikum Erfurt

Erfurt, , Germany

Site Status

University Hospital Frankfurt

Frankfurt, , Germany

Site Status

University Medical Center Göttingen

Göttingen, , Germany

Site Status

Asklepios Klinik Altona, Hamburg

Hamburg, , Germany

Site Status

University Hospital Hamburg Eppendorf

Hamburg, , Germany

Site Status

University Medical Center Mannheim

Mannheim, , Germany

Site Status

Universitätsklinikum der Technischen Universität München

München, , Germany

Site Status

University Hospital Münster

Münster, , Germany

Site Status

Klinikum Nürnberg

Nuremberg, , Germany

Site Status

Klinikum VEST GmbH

Recklinghausen, , Germany

Site Status

Klinikum der Landeshauptstadt Stuttgart gKAöR

Stuttgart, , Germany

Site Status

Hadassah-Hebrew University Medical Center

Jerusalem, , Israel

Site Status

Maggiore Hospital

Bologna, , Italy

Site Status

Careggi University Hospital,

Florence, , Italy

Site Status

Antonio Cardarelli Hospital

Napoli, , Italy

Site Status

San Giovanni Bosco Hospital

Torino, , Italy

Site Status

Amsterdam University Medical Center

Amsterdam, , Netherlands

Site Status

Rijnstate Hospital Arnhem

Arnhem, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Radboud University Medical Center Nijmegen

Nijmegen, , Netherlands

Site Status

Erasmus MC University Medical Center Rotterdam

Rotterdam, , Netherlands

Site Status

Haaglanden Medical Center

The Hague, , Netherlands

Site Status

Lisbon Central University Hospital

Lisbon, , Portugal

Site Status

Hospital Clinico Barcelona

Barcelona, , Spain

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

University Hospital Germans Trias i Pujol

Barcelona, , Spain

Site Status

University Hospital Doctor Josep Trueta, Girona

Girona, , Spain

Site Status

University Hospital Clínico San Carlos, Madrid

Madrid, , Spain

Site Status

University Hospital Virgen de la Arrixaca, Murcia

Murcia, , Spain

Site Status

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Site Status

Skane University Hospital

Lund, , Sweden

Site Status

Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology

Aarau, , Switzerland

Site Status

Department of Interventional and Diagnostical Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel

Basel, , Switzerland

Site Status

Department of Neurology, University Hospital Basel

Basel, , Switzerland

Site Status

Inselspital Bern, University Clinic for Neuroradiology

Bern, , Switzerland

Site Status

Geneva University Hospitals, Interventional Neuroradiology Unit

Geneva, , Switzerland

Site Status

Centre hospitalier universitaire vaudois, CHUV

Lausanne, , Switzerland

Site Status

Kantonsspital Luzern

Lucerne, , Switzerland

Site Status

Neurocentro (EOC) della Svizzera Italiana Stroke Center, Servizio di Neurologia, Ospedale Civico

Lugano, , Switzerland

Site Status

Kantonsspital St Gallen

Sankt Gallen, , Switzerland

Site Status

University Hospital Zurich, Departement of Neuroradiology

Zurich, , Switzerland

Site Status

Barts NHS Health Trust

London, , United Kingdom

Site Status

Countries

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Belgium Finland Germany Israel Italy Netherlands Portugal Spain Sweden Switzerland United Kingdom

References

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Marios-Nikos P, Alex B, Jens F, Isabel F, Jan G, Mira K, Ronen L, Paolo M, Marc R, Jeffrey L S, Daniel S, Adriaan VE, Claus Z, Nikki R, Luzia B, Urs F. EnDovascular therapy plus best medical treatment (BMT) versus BMT alone for medIum distal veSsel occlusion sTroke (DISTAL): An international, multicentre, randomized-controlled, two-arm, assessor-blinded trial. Eur Stroke J. 2024 Dec;9(4):1083-1092. doi: 10.1177/23969873241250212. Epub 2024 May 3.

Reference Type BACKGROUND
PMID: 38702876 (View on PubMed)

Psychogios M, Brehm A, Ribo M, Rizzo F, Strbian D, Raty S, Arenillas JF, Martinez-Galdamez M, Hajdu SD, Michel P, Gralla J, Piechowiak EI, Kaiser DPO, Puetz V, Van den Bergh F, De Raedt S, Bellante F, Dusart A, Hellstern V, Khanafer A, Parrilla G, Morales A, Kirschke JS, Wunderlich S, Fiehler J, Thomalla G, Lemmens R, Peluso JP, Bolognese M, von Hessling A, van Es A, Kruyt ND, Coutinho JM, Castano C, Minnerup J, van Zwam W, Dhondt E, Nolte CH, Machi P, Loehr C, Mattle HP, Buhk JH, Kaesmacher J, Dobrocky T, Papanagiotou P, Alonso A, Holtmannspoetter M, Zini A, Renieri L, Keil F, van den Wijngaard I, Kagi G, Terceno M, Wiesmann M, Amaro S, Rommers N, Balmer L, Fragata I, Katan M, Leker RR, Saver JL, Staals J, Fischer U; DISTAL Investigators. Endovascular Treatment for Stroke Due to Occlusion of Medium or Distal Vessels. N Engl J Med. 2025 Apr 10;392(14):1374-1384. doi: 10.1056/NEJMoa2408954. Epub 2025 Feb 5.

Reference Type DERIVED
PMID: 39908430 (View on PubMed)

Other Identifiers

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2021-01692; qu20Psychogios2

Identifier Type: -

Identifier Source: org_study_id