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NCT05029414Active, not recruiting

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

EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum VeSsel Occlusion sTroke - a prAgmatic, International, Multicentre, Randomized triaL (DISTAL)

Source: ClinicalTrials.gov · Last updated 24 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
543 (actual)
First submitted
26 Aug 2021
Start date
9 Dec 2021
Primary completion date
10 Oct 2024
Lead sponsor
University Hospital, Basel, Switzerland
Diseases
Stroke
NCT number
NCT05029414

What you commit to

  • Study type: Interventional
  • Participants enrolled: 543
  • From 9 Dec 2021 to the primary completion date, 10 Oct 2024
  • 56 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Evidence of vessel recanalization prior to randomisation

Other illness

  • Acute intracranial haemorrhage
  • In-Hospital Stroke
  • 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

Other

  • Patient bedridden or presenting from a nursing home
  • 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.
  • 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
  • Participation in another interventional trial

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (56)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Az Sint Jan Brugge
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BrugesBelgiumUnknown status
Hôpital Civil Marie Curie Charleroi
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CharleroiBelgiumUnknown status
UZ Universiteit Gent
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GhentBelgiumUnknown status
AZ Groeninge
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KortrijkBelgiumUnknown status
Universitair Ziekenhuis Leuven
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LeuvenBelgiumUnknown status
Clinique CHC MontLégia
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LiègeBelgiumUnknown status
Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology
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AarauSwitzerlandUnknown status
Department of Interventional and Diagnostical Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel
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BaselSwitzerlandUnknown status
Department of Neurology, University Hospital Basel
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BaselSwitzerlandUnknown status
Inselspital Bern, University Clinic for Neuroradiology
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BernSwitzerlandUnknown status
Geneva University Hospitals, Interventional Neuroradiology Unit
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GenevaSwitzerlandUnknown status
Centre Hospitalier Universitaire Vaudois (CHUV)
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LausanneSwitzerlandUnknown status
Kantonsspital Luzern
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LucerneSwitzerlandUnknown status
Neurocentro (EOC) della Svizzera Italiana Stroke Center, Servizio di Neurologia, Ospedale Civico
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LuganoSwitzerlandUnknown status
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandUnknown status
University Hospital Zurich, Departement of Neuroradiology
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ZurichSwitzerlandUnknown status
Uniklinik RHTW Aachen
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AachenGermanyUnknown status
Charité Universitätsmedizin Berlin
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BerlinGermanyUnknown status
Klinikum Bremen-Mitte
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BremenGermanyUnknown status
Uniklinikum Dresden
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DresdenGermanyUnknown status
Helios Klinikum Erfurt
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ErfurtGermanyUnknown status
University Hospital Frankfurt
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FrankfurtGermanyUnknown status
University Medical Center Göttingen
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GöttingenGermanyUnknown status
Asklepios Klinik Altona Hamburg
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HamburgGermanyUnknown status
University hospital Hamburg Eppendorf
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HamburgGermanyUnknown status
University Medical Center Mannheim
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MannheimGermanyUnknown status
Universitätsklinikum der Technischen Universität München
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MünchenGermanyUnknown status
University Hospital Munster
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MünsterGermanyUnknown status
Klinikum Nürnberg
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NurembergGermanyUnknown status
Klinikum VEST GmbH
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RecklinghausenGermanyUnknown status
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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StuttgartGermanyUnknown status
University Hospital Germans Trias i Pujol
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BarcelonaSpainUnknown status
Hospital Clinico Barcelona
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BarcelonaSpainUnknown status
Hospital Vall d'Hebron
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BarcelonaSpainUnknown status
University Hospital Doctor Josep Trueta, Girona
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GironaSpainUnknown status
University Hospital Clínico San Carlos, Madrid
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MadridSpainUnknown status
University Hospital Virgen de la Arrixaca, Murcia
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MurciaSpainUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status
Helsinki University Hospital
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HelsinkiFinlandUnknown status
Turku University Hospital
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TurkuFinlandUnknown status
Barts NHS Health Trust
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LondonUnited KingdomUnknown status
Hadassah Hebrew University Medical Center
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JerusalemIsraelUnknown status
Maggiore Hospital
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BolognaItalyUnknown status
Careggi University Hospital
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FlorenceItalyUnknown status
Antonio Cardarelli Hospital
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NaplesItalyUnknown status
San Giovanni Bosco Hospital
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TorinoItalyUnknown status
Amsterdam University Medical Center
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AmsterdamNetherlandsUnknown status
Rijnstate Hospital Arnhem
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ArnhemNetherlandsUnknown status
University Medical Center Groningen
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GroningenNetherlandsUnknown status
Leiden University Medical Center
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LeidenNetherlandsUnknown status
Maastricht University Medical Center
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MaastrichtNetherlandsUnknown status
Radboud university medical center Nijmegen
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NijmegenNetherlandsUnknown status
Erasmus MC, University Medical Center Rotterdam
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RotterdamNetherlandsUnknown status
Haaglanden Medical Center
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The HagueNetherlandsUnknown status
Lisbon Central University Hospital
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LisbonPortugalUnknown status
Skåne University Hospital
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LundSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.