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

NCT05029414 | Active Not Recruiting DMC

• 1 other identifier: 2021-01692; qu20Psychogios2
• Study Type: interventional
• Target: 543
• Locations: 11 countries
• Sites: 56

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Medium Vessel Occlusion; Endovascular Therapy

Outcome Measures

Primary Outcomes (1)

• Degree of dependency and disability in everyday life (measured with the mRS)

  The primary outcome is the degree of dependency and disability in everyday life (measured with the mRS) at 90 days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).

  at 90 days (± 14 days) after randomisation

Secondary Outcomes (7)

• Change in National Institutes of Health Stroke Scale (NIHSS)

  24 hours post-randomization (+/- 6 hours)

• Assessment of Cognitive function using the validated Montreal cognitive assessment (MoCA)

  at 90 days (± 14 days) after randomisation

• Change in Quality of life as assessed by the EuroQol-5D

  at 90 ± 14 days and at 1 year after randomisation

• Degree of dependency and disability in everyday life (measured with the mRS)

  at one year (± 30 days) after randomisation

• Patient residential status

  at one year (± 30 days) after randomisation

Other Outcomes (3)

• Change in All-cause mortality (Safety Outcome)

  at days 7-10 or discharge if earlier, 90 day ± 14 days; and one year ± 30 days after randomisation.

• Change in Serious Adverse Events (SAEs)

  at 24 h ± 6h, days 7-10 or discharge if earlier and at 90 ± 14 days after randomisation

• Change in symptomatic intracranial haemorrhage

  at 24 ± 6 hours post randomisation

Study Arms (2)

Intervention group: EVT + BMT

EXPERIMENTAL

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.

Procedure: Endovascular Therapy

Control group: BMT

NO INTERVENTION

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.

Interventions

Endovascular Therapy 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.

Intervention group: EVT + BMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Fund for Scientific Research: collaborator
• Stryker Neurovascular: collaborator
• Penumbra Inc.: collaborator
• Medtronic: collaborator
• Phenox GmbH: collaborator
• Rapid Medical: collaborator
• Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel: collaborator

Study Sites (56)

AZ Sint-Jan Brugge

Bruges, Belgium

Location

Hôpital Civil Marie Curie Charleroi

Charleroi, Belgium

Location

UZ Universiteit Gent

Ghent, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, Belgium

Location

Clinique CHC MontLégia

Liège, Belgium

Location

Helsinki University Hospital

Helsinki, Finland

Location

Turku University Hospital

Turku, Finland

Location

Uniklinik RHTW Aachen

Aachen, Germany

Location

Charité-Universitätsmedizin Berlin

Berlin, Germany

Location

Klinikum Bremen-Mitte

Bremen, Germany

Location

Uniklinikum Dresden

Dresden, Germany

Location

Helios Klinikum Erfurt

Erfurt, Germany

Location

University Hospital Frankfurt

Frankfurt, Germany

Location

University Medical Center Göttingen

Göttingen, Germany

Location

Asklepios Klinik Altona, Hamburg

Hamburg, Germany

Location

University Hospital Hamburg Eppendorf

Hamburg, Germany

Location

University Medical Center Mannheim

Mannheim, Germany

Location

Universitätsklinikum der Technischen Universität München

München, Germany

Location

University Hospital Münster

Münster, Germany

Location

Klinikum Nürnberg

Nuremberg, Germany

Location

Klinikum VEST GmbH

Recklinghausen, Germany

Location

Klinikum der Landeshauptstadt Stuttgart gKAöR

Stuttgart, Germany

Location

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

Location

Maggiore Hospital

Bologna, Italy

Location

Careggi University Hospital,

Florence, Italy

Location

Antonio Cardarelli Hospital

Napoli, Italy

Location

San Giovanni Bosco Hospital

Torino, Italy

Location

Amsterdam University Medical Center

Amsterdam, Netherlands

Location

Rijnstate Hospital Arnhem

Arnhem, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Radboud University Medical Center Nijmegen

Nijmegen, Netherlands

Location

Erasmus MC University Medical Center Rotterdam

Rotterdam, Netherlands

Location

Haaglanden Medical Center

The Hague, Netherlands

Location

Lisbon Central University Hospital

Lisbon, Portugal

Location

Hospital Clinico Barcelona

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

University Hospital Germans Trias i Pujol

Barcelona, Spain

Location

University Hospital Doctor Josep Trueta, Girona

Girona, Spain

Location

University Hospital Clínico San Carlos, Madrid

Madrid, Spain

Location

University Hospital Virgen de la Arrixaca, Murcia

Murcia, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Location

Skane University Hospital

Lund, Sweden

Location

Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology

Aarau, 5001, Switzerland

Location

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

Basel, 4031, Switzerland

Location

Department of Neurology, University Hospital Basel

Basel, 4031, Switzerland

Location

Inselspital Bern, University Clinic for Neuroradiology

Bern, 3010, Switzerland

Location

Geneva University Hospitals, Interventional Neuroradiology Unit

Geneva, 1211, Switzerland

Location

Centre hospitalier universitaire vaudois, CHUV

Lausanne, 1011, Switzerland

Location

Kantonsspital Luzern

Lucerne, Switzerland

Location

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

Lugano, 6900, Switzerland

Location

Kantonsspital St Gallen

Sankt Gallen, Switzerland

Location

University Hospital Zurich, Departement of Neuroradiology

Zurich, 8091, Switzerland

Location

Barts NHS Health Trust

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38702876 BACKGROUND

• 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.

  PMID: 39908430 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marios-Nikos Psychogios, Prof.Dr.

  Department of Interventional and Diagnostical Neuroradiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

• Urs Fischer, Prof.Dr.

  Neurology, Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, parallel group, randomized, open label, superiority trial with blinded endpoint assessment

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 31, 2021
• Study Start: December 9, 2021
• Primary Completion: October 10, 2024
• Study Completion: June 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

IT (4); BE (6); SE (1); FI (2); ES (7); CH (10); DE (15); PT (1); NL (8); IL (1); GB (1)