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Speeding stroke care: direct to angio suite could save brain tissue

NCT ID NCT04701684

Disease control Sponsor: Philips Clinical & Medical Affairs Global Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether taking stroke patients directly to a special imaging and treatment room (angio suite) speeds up care compared to the usual approach of getting a CT or MRI first. About 594 adults with severe stroke symptoms will be randomly assigned to one of the two paths. The goal is to see if the faster workflow leads to better recovery at 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Direct to Angio Suite (DTAS) workflow using Philips' CBCT imaging device
What this could lead to
If successful, this workflow could reduce treatment delays for stroke patients, potentially leading to better recovery and less disability.
What could go wrong
This is a workflow study, not a new drug or device. Results depend on hospital logistics and may not apply to all stroke centers. The trial is still recruiting, so outcomes are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 594 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject is 18 years of age or older, or of legal age to give informed consent per state or national law. * Baseline NIHSS score obtained prior to randomization must be equal or higher than 10 points. * Subjects with no significant pre-stroke functional disability (modified Rankin scale 0 - 2). * Subjects suspected of acute ischemic stroke with an estimated arrival time at a stroke center (clinical investigational site participating in this study) \< 6 hours from symptom onset OR wake-up stroke with time last known well of \< 12 hours and symptoms discovered within 6 hours from arrival time at a stroke center. Symptom onset is defined as point in time the patient was last known well (at baseline). * Informed consent obtained from patient or his or her legally designated representative (if locally required). * Angiography suite immediately available. * Endovascular treatment team immediately available (Neurologist, Neurointerventionalist, Anesthesiologist, Nursing, Technicians as per local standard practice) Exclusion Criteria: Clinical exclusion criteria: * Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0 * Known baseline platelet count \< 30.000/μL * Baseline blood glucose of \< 50mg/dL (\< 2.78mmol/l) * For patients receiving thrombolysis: severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg). Note: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA/ASA guidelines recommended medication (including IV antihypertensive drips), the patient can be enrolled. * Patients from a transfer center (Primary Stroke Center) with a CT/MR that is not required to be redone in the Comprehensive Stroke Center as per discretion of the physician or per local standards (e.g. CT/MR less than 90 minutes old). * Patients in coma (NIHSS item of consciousness \>1) defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation). * Patients with extreme vomiting * Patients that are extremely agitated * Seizures at stroke onset which would preclude obtaining a baseline NIHSS * Serious, advanced, or terminal illness with anticipated life expectancy of less than one year. * Patients acquired stroke while in-hospital * History of life-threatening allergy (more than rash) to contrast medium * Cerebral vasculitis * Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.) * Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas). * Patients with unstable clinical status who require emergent life support care * Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. * Subject participates in a potentially confounding drug or device trial during the course of the study. * Woman of childbearing potential who is known to be pregnant on admission. * Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman) * Subject is Philips employee or their family members residing with this Philips employee.

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Conditions

The condition(s) this trial relates to.

cerebral artery occlusion stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke, acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baptist Medical Center

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Bicêtre Hospital

    RECRUITING

    Paris, France

  • CHU Montpellier

    RECRUITING

    Montpellier, France

  • Grady Memorial Hospital/Emory University

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30303, United States

  • Haaglanden Medical Center

    WITHDRAWN

    The Hague, Netherlands

  • Hospices Civils de Lyon

    COMPLETED

    Lyon, France

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, Moncloa - Aravaca, 28040, Spain

  • Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba

    RECRUITING

    Vitória, Brazil

  • Hospital Geral de Fortaleza

    RECRUITING

    Fortaleza, Brazil

  • Hospital Universitari Doctor Josep Trueta de Girona

    RECRUITING

    Girona, Spain

  • Hospital Virgen del Rocio

    RECRUITING

    Seville, Spain

  • Hospital de Base

    NOT_YET_RECRUITING

    São José do Rio Preto, Brazil

  • Klinikum Kassel

    RECRUITING

    Kassel, Germany

  • Klinikum rechts der Isar der TU München

    RECRUITING

    Munich, Germany

  • La Sagrada Familia Clinic

    RECRUITING

    José Hernández, Argentina

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • St. Antonius Ziekenhuis

    COMPLETED

    Nieuwegein, Netherlands

  • UZ Brussels

    RECRUITING

    Brussels, Belgium

  • University Emergency Hospital Bucharest

    NOT_YET_RECRUITING

    Bucharest, Romania

  • University Hospital Bonn (UKB Universitätsklinikum Bonn)

    RECRUITING

    Bonn, 53127, Germany

  • Universitätsklinikum Schleswig-Holstein Lübeck

    RECRUITING

    Lübeck, 23562, Germany

  • Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, Spain

  • İstanbul Aydin University medical park florya hospital

    COMPLETED

    Istanbul, Turkey (Türkiye)

  • İstinye Üniversitesi Gaziosmanpaşa Hastanesi

    NOT_YET_RECRUITING

    Istanbul, Turkey (Türkiye)

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