Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in the Netherlands / NCT05029414
Active, not recruiting Not applicable

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

NCT05029414 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2021-12-09
Last updated
2024-12-24

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

Endovascular Therapy

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
AZ Sint-Jan Brugge Bruges Belgium
Hôpital Civil Marie Curie Charleroi 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

+ 16 more sites — see the full list on the official registry below.

More University Hospital, Basel, Switzerland trials in the Netherlands

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05029414 on ClinicalTrials.gov ↗ ← All trials in the Netherlands