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
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Az Sint Jan Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Hôpital Civil Marie Curie Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| UZ Universiteit Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| Universitair Ziekenhuis Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Clinique CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology Coordinator of this site? Confirm its status | Aarau | Switzerland | Unknown status |
| Department of Interventional and Diagnostical Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Department of Neurology, University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Bern, University Clinic for Neuroradiology Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Geneva University Hospitals, Interventional Neuroradiology Unit Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Centre Hospitalier Universitaire Vaudois (CHUV) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Kantonsspital Luzern Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| Neurocentro (EOC) della Svizzera Italiana Stroke Center, Servizio di Neurologia, Ospedale Civico Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| University Hospital Zurich, Departement of Neuroradiology Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Uniklinik RHTW Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Klinikum Bremen-Mitte Coordinator of this site? Confirm its status | Bremen | Germany | Unknown status |
| Uniklinikum Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Helios Klinikum Erfurt Coordinator of this site? Confirm its status | Erfurt | Germany | Unknown status |
| University Hospital Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| University Medical Center Göttingen Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| Asklepios Klinik Altona Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| University hospital Hamburg Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| University Medical Center Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Universitätsklinikum der Technischen Universität München Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| University Hospital Munster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Klinikum Nürnberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Klinikum VEST GmbH Coordinator of this site? Confirm its status | Recklinghausen | Germany | Unknown status |
| Klinikum Der Landeshauptstadt Stuttgart gKAöR Coordinator of this site? Confirm its status | Stuttgart | Germany | Unknown status |
| University Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinico Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| University Hospital Doctor Josep Trueta, Girona Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| University Hospital Clínico San Carlos, Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| University Hospital Virgen de la Arrixaca, Murcia Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
| Barts NHS Health Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Hadassah Hebrew University Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Maggiore Hospital Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Antonio Cardarelli Hospital Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| San Giovanni Bosco Hospital Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Amsterdam University Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Rijnstate Hospital Arnhem Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Radboud university medical center Nijmegen Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Erasmus MC, University Medical Center Rotterdam Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Haaglanden Medical Center Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| Lisbon Central University Hospital Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.