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

Acute Ischemic Stroke Clinical Trial

— DISTAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029414
• Other study ID #: 2021-01692; qu20Psychogios2
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Marios-Nikos Psychogios, Prof.Dr.
• Phone: +41 61 328 59 36
• Email: distal[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 526
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	Hôpital Civil Marie Curie Charleroi	Charleroi
Belgium	UZ Universiteit Gent	Gent
Belgium	AZ Groeninge	Groeninge
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	Clinique CHC MontLégia	Liege
Finland	Helsinki University Hospital	Helsinki
Germany	Uniklinik RHTW Aachen	Aachen
Germany	Charité-Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Knappschaftskrankenhaus Bochum	Bochum
Germany	Uniklinikum Dresden	Dresden
Germany	University Hospital Hamburg Eppendorf	Hamburg
Germany	LMU Klinikum München	München
Germany	Universitätsklinikum der Technischen Universität München	München
Germany	Klinikum Nürnberg	Nürnberg
Germany	Klinikum VEST GmbH	Recklinghausen
Germany	Klinikum der Landeshauptstadt Stuttgart gKAöR	Stuttgart
Spain	Hospital Clinico Barcelona	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	University Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Switzerland	Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology	Aarau
Switzerland	Department of Interventional and Diagnostical Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel	Basel
Switzerland	Department of Neurology, University Hospital Basel	Basel
Switzerland	Inselspital Bern, University Clinic for Neuroradiology	Bern
Switzerland	Geneva University Hospitals, Interventional Neuroradiology Unit	Genf
Switzerland	Centre hospitalier universitaire vaudois, CHUV	Lausanne
Switzerland	Neurocentro (EOC) della Svizzera Italiana Stroke Center, Servizio di Neurologia, Ospedale Civico	Lugano
Switzerland	Kantonsspital Luzern	Luzern
Switzerland	Kantonsspital St Gallen	Saint Gallen
Switzerland	University Hospital Zurich, Departement of Neuroradiology	Zürich
United Kingdom	Barts NHS Health Trust	London
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent

Sponsors (8)

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

Countries where clinical trial is conducted

Belgium,  Finland,  Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Change in Serious Adverse Events (SAEs)	Change in Serious Adverse Events (SAEs)	at 24 h ± 6h, days 7-10 or discharge if earlier and at 90 ± 14 days after randomisation
Other	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
Primary	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	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.	24 hours post-randomization (+/- 6 hours)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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