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| Name | Class |
|---|---|
| Swiss National Fund for Scientific Research | OTHER |
| Stryker Neurovascular | INDUSTRY |
| Penumbra Inc. | INDUSTRY |
| Medtronic |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in National Institutes of Health Stroke Scale (NIHSS) | The scale is made up of 11 different elements that evaluate specific ability. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in All-cause mortality (Safety Outcome) | Change in All-cause mortality | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan Brugge | Bruges | Belgium | ||||
| Hôpital Civil Marie Curie Charleroi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38702876 | Background | 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. | |
| 42105785 |
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| INDUSTRY |
| Phenox GmbH | INDUSTRY |
| Rapid Medical | INDUSTRY |
| Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel | OTHER |
Pragmatic, parallel group, randomized, open label, superiority trial with blinded endpoint assessment
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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.
|
| 24 hours post-randomization (+/- 6 hours) |
| Assessment of Cognitive function using the validated Montreal cognitive assessment (MoCA) | MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. | at 90 days (± 14 days) after randomisation |
| Change in Quality of life as assessed by the EuroQol-5D | The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. the descriptive system produces a 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions | at 90 ± 14 days and at 1 year after randomisation |
| Degree of dependency and disability in everyday life (measured with the mRS) | Degree of dependency and disability in everyday life (measured with the mRS). The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6). | at one year (± 30 days) after randomisation |
| Patient residential status | Patient residential status will be obtained through a telephone call to the patient or if not available his next of kin/caregiver one year (± 30 days) after randomisation | at one year (± 30 days) after randomisation |
| Change in percentage of penumbral tissue saved (Imaging Data Evaluation) | Percentage of penumbral tissue saved (Imaging Data Evaluation): It is defined as the proportion of tissue at risk (defined as the mismatch volume derived from with RAPID Compute tomography perfusion (CTP) (IschemaView Inc.) at baseline that did not progress to infarction at 24h (derived from Magnet Resonance Imaging (MRI) (FLAIR and Diffusion Weighted Imaging (DWI)) or NCCT imaging. | at baseline and post-interventional at 24 hours (± 6 hours) post-randomisation |
| Radiologic occurrence of intracranial haemorrhages | Radiologic occurrence of intracranial haemorrhages graded according to the modified Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition | within 24 hours (± 6 hours) post 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 | Change in symptomatic intracranial haemorrhage by radiologic categorization on the basis of the pre-randomisation imaging at day 0 (Non contrast computed tomography (NCCT)/Magnet Resonance Imaging (MRI), Computed tomography angiography (CTA)/Magnetic Resonance Angiography (MRA), Diffusion Weighted Imaging (DWI)/Perfusion Weighted Imaging (PWI) MRI, Compute tomography (CT) perfusion) and the post-interventional imaging at 24 ± 6 hours. | at 24 ± 6 hours post randomisation |
| Charleroi |
| Belgium |
| UZ Universiteit Gent | Ghent | Belgium |
| AZ Groeninge | Kortrijk | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | Belgium |
| Clinique CHC MontLégia | Liège | Belgium |
| Helsinki University Hospital | Helsinki | Finland |
| Turku University Hospital | Turku | Finland |
| Uniklinik RHTW Aachen | Aachen | Germany |
| Charité-Universitätsmedizin Berlin | Berlin | Germany |
| Klinikum Bremen-Mitte | Bremen | Germany |
| Uniklinikum Dresden | Dresden | Germany |
| Helios Klinikum Erfurt | Erfurt | Germany |
| University Hospital Frankfurt | Frankfurt | Germany |
| University Medical Center Göttingen | Göttingen | Germany |
| Asklepios Klinik Altona, Hamburg | Hamburg | Germany |
| University Hospital Hamburg Eppendorf | Hamburg | Germany |
| University Medical Center Mannheim | Mannheim | Germany |
| Universitätsklinikum der Technischen Universität München | München | Germany |
| University Hospital Münster | Münster | Germany |
| Klinikum Nürnberg | Nuremberg | Germany |
| Klinikum VEST GmbH | Recklinghausen | Germany |
| Klinikum der Landeshauptstadt Stuttgart gKAöR | Stuttgart | Germany |
| Hadassah-Hebrew University Medical Center | Jerusalem | Israel |
| Maggiore Hospital | Bologna | Italy |
| Careggi University Hospital, | Florence | Italy |
| Antonio Cardarelli Hospital | Naples | Italy |
| San Giovanni Bosco Hospital | Torino | Italy |
| Amsterdam University Medical Center | Amsterdam | Netherlands |
| Rijnstate Hospital Arnhem | Arnhem | Netherlands |
| University Medical Center Groningen | Groningen | Netherlands |
| Leiden University Medical Center | Leiden | Netherlands |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Radboud University Medical Center Nijmegen | Nijmegen | Netherlands |
| Erasmus MC University Medical Center Rotterdam | Rotterdam | Netherlands |
| Haaglanden Medical Center | The Hague | Netherlands |
| Lisbon Central University Hospital | Lisbon | Portugal |
| Hospital Clinico Barcelona | Barcelona | Spain |
| Hospital Vall d'Hebron | Barcelona | Spain |
| University Hospital Germans Trias i Pujol | Barcelona | Spain |
| University Hospital Doctor Josep Trueta, Girona | Girona | Spain |
| University Hospital Clínico San Carlos, Madrid | Madrid | Spain |
| University Hospital Virgen de la Arrixaca, Murcia | Murcia | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | Spain |
| Skane University Hospital | Lund | Sweden |
| Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology | Aarau | 5001 | Switzerland |
| Department of Interventional and Diagnostical Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel | Basel | 4031 | Switzerland |
| Department of Neurology, University Hospital Basel | Basel | 4031 | Switzerland |
| Inselspital Bern, University Clinic for Neuroradiology | Bern | 3010 | Switzerland |
| Geneva University Hospitals, Interventional Neuroradiology Unit | Geneva | 1211 | Switzerland |
| Centre hospitalier universitaire vaudois, CHUV | Lausanne | 1011 | Switzerland |
| Kantonsspital Luzern | Lucerne | Switzerland |
| Neurocentro (EOC) della Svizzera Italiana Stroke Center, Servizio di Neurologia, Ospedale Civico | Lugano | 6900 | Switzerland |
| Kantonsspital St Gallen | Sankt Gallen | Switzerland |
| University Hospital Zurich, Departement of Neuroradiology | Zurich | 8091 | Switzerland |
| Barts NHS Health Trust | London | United Kingdom |
| Derived |
| Fischer U, 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, Fragata I, Katan M, Leker RR, Saver JL, Staals J, Rommers N, Balmer L, Psychogios M; DISTAL investigators. Endovascular treatment for medium or distal vessel occlusion stroke (DISTAL): 12-month outcomes of a multicentre, open-label, randomised trial. Lancet Neurol. 2026 Jun;25(6):571-580. doi: 10.1016/S1474-4422(26)00169-9. Epub 2026 May 6. |
| 39908430 | Derived | 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. |
| 38666480 | Derived | Broocks G, Kniep H, McDonough R, Bechstein M, Heitkamp C, Winkelmeier L, Klapproth S, Faizy TD, Schell M, Schon G, Hanning U, Gellissen S, Kemmling A, Papanagiotou P, Fiehler J, Meyer L. Thrombectomy in ischemic stroke patients with large core but minor ischemic changes on non-enhanced computed tomography. Int J Stroke. 2024 Aug;19(7):764-771. doi: 10.1177/17474930241249588. Epub 2024 May 10. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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