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Acute Ischemic StrokeDISTALNCT05029414

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

A study testing Endovascular Therapy in people with Acute Ischemic Stroke, run by University Hospital, Basel, Switzerland at 56 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Endovascular Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
543 participants
Where
56 sitesin 11 countries
Study dates
9 Dec 2021to 1 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

56 sites in 11 countries.

56 sites in 11 countries

Germany15 sites

  • Uniklinik RHTW Aachen

    Aachen

  • Charité-Universitätsmedizin Berlin

    Berlin

  • Klinikum Bremen-Mitte

    Bremen

  • Uniklinikum Dresden

    Dresden

  • Helios Klinikum Erfurt

    Erfurt

  • University Hospital Frankfurt

    Frankfurt

  • University Medical Center Göttingen

    Göttingen

  • Asklepios Klinik Altona, Hamburg

    Hamburg

  • University Hospital Hamburg Eppendorf

    Hamburg

  • University Medical Center Mannheim

    Mannheim

  • Universitätsklinikum der Technischen Universität München

    München

  • University Hospital Münster

    Münster

  • Klinikum Nürnberg

    Nuremberg

  • Klinikum VEST GmbH

    Recklinghausen

  • Klinikum der Landeshauptstadt Stuttgart gKAöR

    Stuttgart

Other trials in Germany

Switzerland10 sites

  • Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology

    Aarau, 5001

  • Department of Interventional and Diagnostical Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel

    Basel, 4031

  • Department of Neurology, University Hospital Basel

    Basel, 4031

  • Inselspital Bern, University Clinic for Neuroradiology

    Bern, 3010

  • Geneva University Hospitals, Interventional Neuroradiology Unit

    Geneva, 1211

  • Centre hospitalier universitaire vaudois, CHUV

    Lausanne, 1011

  • Kantonsspital Luzern

    Lucerne

  • Neurocentro (EOC) della Svizzera Italiana Stroke Center, Servizio di Neurologia, Ospedale Civico

    Lugano, 6900

  • Kantonsspital St Gallen

    Sankt Gallen

  • University Hospital Zurich, Departement of Neuroradiology

    Zurich, 8091

Other trials in Switzerland

Netherlands8 sites

  • Amsterdam University Medical Center

    Amsterdam

  • Rijnstate Hospital Arnhem

    Arnhem

  • University Medical Center Groningen

    Groningen

  • Leiden University Medical Center

    Leiden

  • Maastricht University Medical Center

    Maastricht

  • Radboud University Medical Center Nijmegen

    Nijmegen

  • Erasmus MC University Medical Center Rotterdam

    Rotterdam

  • Haaglanden Medical Center

    The Hague

Other trials in Netherlands

Spain7 sites

  • Hospital Clinico Barcelona

    Barcelona

  • Hospital Vall d'Hebron

    Barcelona

  • University Hospital Germans Trias i Pujol

    Barcelona

  • University Hospital Doctor Josep Trueta, Girona

    Girona

  • University Hospital Clínico San Carlos, Madrid

    Madrid

  • University Hospital Virgen de la Arrixaca, Murcia

    Murcia

  • Hospital Clinico Universitario de Valladolid

    Valladolid

Other trials in Spain

Belgium6 sites

  • AZ Sint-Jan Brugge

    Bruges

  • Hôpital Civil Marie Curie Charleroi

    Charleroi

  • UZ Universiteit Gent

    Ghent

  • AZ Groeninge

    Kortrijk

  • Universitair Ziekenhuis Leuven

    Leuven

  • Clinique CHC MontLégia

    Liège

Other trials in Belgium

Italy4 sites

  • Maggiore Hospital

    Bologna

  • Careggi University Hospital,

    Florence

  • Antonio Cardarelli Hospital

    Naples

  • San Giovanni Bosco Hospital

    Torino

Other trials in Italy

Finland2 sites

  • Helsinki University Hospital

    Helsinki

  • Turku University Hospital

    Turku

Other trials in Finland

Israel1 site

  • Hadassah-Hebrew University Medical Center

    Jerusalem

Other trials in Israel

Portugal1 site

  • Lisbon Central University Hospital

    Lisbon

Other trials in Portugal

Sweden1 site

  • Skane University Hospital

    Lund

Other trials in Sweden

United Kingdom1 site

  • Barts NHS Health Trust

    London

Other trials in United Kingdom

About this study

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

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.

Read the detailed 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.

Being tested
Endovascular Therapy
Keywords
Stroke, Medium Vessel Occlusion, Endovascular Therapy
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular TherapyProcedure or surgery

    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 groups in NCT05029414
Study groupRoleWhat they receive
Intervention group: EVT + BMTExperimentalPatients 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.
Receives: Procedure: Endovascular Therapy
Control group: BMTNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: at 90 days (± 14 days) after randomisation

Secondary outcomes (7)

  1. 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.

    Measured: 24 hours post-randomization (+/- 6 hours)

  2. 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.

    Measured: at 90 days (± 14 days) after randomisation

  3. 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

    Measured: at 90 ± 14 days and at 1 year after randomisation

  4. 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).

    Measured: at one year (± 30 days) after randomisation

  5. 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

    Measured: at one year (± 30 days) after randomisation

  6. 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.

    Measured: at baseline and post-interventional at 24 hours (± 6 hours) post-randomisation

  7. 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

    Measured: within 24 hours (± 6 hours) post randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start9 Dec 2021
  3. Primary completion10 Oct 2024
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic, parallel group, randomized, open label, superiority trial with blinded endpoint assessment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05029414
Sponsor's protocol ID
2021-01692; qu20Psychogios2
Acronym
DISTAL
Status last verified
Dec 2024
First submitted
26 Aug 2021
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38702876

  • 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.

    PubMed 42105785

  • 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.

    PubMed 39908430

  • 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.

    PubMed 38666480

Questions about this trial

What is this clinical trial studying?

A study testing Endovascular Therapy in people with Acute Ischemic Stroke, run by University Hospital, Basel, Switzerland at 56 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Germany, Switzerland, Netherlands, Spain, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of dependency and disability in everyday life (measured with the mRS) (time frame: at 90 days (± 14 days) after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05029414, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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