Stroke AcuteGET-FASTNCT07052045
One-Stop manaGemEnT For A Swift Initiation of Endovascular Therapy
A study testing One Stop Management in people with Stroke Acute and Acute Ischemic Stroke AIS, run by Prof. Dr. Jan Liman at 2 sites in 2 countries.
Trial summary
Stroke, especially acute ischemic stroke (AIS) caused by a blocked blood vessel in the brain, is a leading cause of death and long-term disability. When the blockage is in a large blood vessel, a procedure called endovascular therapy (EVT)-where the clot is removed using a catheter-is highly effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute, Acute Ischemic Stroke AIS, Hemorrhagic Stroke, Intracerebral
- What is being tested?
- One Stop Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Dec 2025to 1 Nov 2028
- Phase
- Interventional
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
- Symptoms suggestive of an acute ischemic stroke caused by a large or medium vessel occlusion as defined by a National Institute of Health Stroke Scale (NIHSS) Score of ≥ 10 points
- Patient presents directly to the treating hospital (mothership patient) within 4.5 hours of last seen well (LSW)
- Age ≥ 18 years
- Patient was independent in daily activities prior to the stroke (pre stroke modified Rankin Scale of 0 - 2)
- Endovascular treatment team available (Neurologist, Interventionist, Anesthesiologist, Nursery, Technicians)
- Informed Consent as documented by signature or fulfilling the criteria for emergency consent procedures
Who cannot join
- Severe comorbidities, which will likely prevent improvement or follow-up
- In-hospital stroke
- Clinical symptoms suggestive of intracranial hemorrhage (deterioration of patient during transport, vomiting or depressed consciousness)
- Strong suspicion of functional neurological symptom disorder / conversion disorder
- Hemodynamically unstable patients who require advanced vital support
- Angiography room occupied by other procedure
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Klinik für Neurologie, Universitätsklinik der Paracelsus
Nuremberg, 90471
Jan Liman, Dr, +49 (0) 911 398-2491, Jan.Liman@klinikum-nuernberg.de
Jan Liman, Dr
Switzerland1 site, 1 recruiting
- Not yet recruiting
University Hospital Basel
Basel, 4031
Alex Brehm, PhD, +41 61 328 79 48, alex.brehm@usb.ch
Marios Psychogios, Dr
About this study
Official title: One-Stop manaGemEnT For A Swift Initiation of Endovascular Therapy - An International, Multicenter, Pragmatic Randomized Controlled Trial (GET-FAST
Stroke, especially acute ischemic stroke (AIS) caused by a blocked blood vessel in the brain, is a leading cause of death and long-term disability. When the blockage is in a large blood vessel, a procedure called endovascular therapy (EVT)-where the clot is removed using a catheter-is highly effective. However, the sooner EVT is done, the better the outcome for the patient.
Research has shown that delays between arriving at the hospital and starting EVT (called door-to-groin time) significantly reduce the chances of recovery. For example, reducing this time by just 15 minutes can mean 20 more patients (out of 1,000 treated) going home instead of to a care facility. Even a 10-minute improvement can result in over 100 extra days of independent living for patients and save more than $10,000 in healthcare costs per patient.
Read more
To reduce these delays, hospitals have improved stroke workflows. In the current standard approach, patients suspected of having a stroke are taken first to a CT scan room to confirm the diagnosis, and then, if a treatable occlusion is found, to a separate room for EVT. This usually takes around 60-70 minutes.
However, moving patients between rooms takes time. A new approach called "One-Stop management" could solve this. In this method, both the brain scan and the EVT procedure are done in one room-the angiography suite-using special imaging tools called flat panel CT (FDCT) and FDCT angiography (FDCT-A).
A previous study with 230 patients showed that One-Stop management is possible and saves time. But there's a challenge: the decision to follow the One-Stop pathway is made before a clear diagnosis is available. That's important because not all strokes benefit from EVT. Severe stroke symptoms (measured by a score called NIHSS ≥10) can come from:
- A large or medium vessel blockage (which EVT can treat),
- A small vessel blockage, or
- A bleed in the brain (hemorrhage). Only the first group benefits from EVT. About 85% of patients with severe symptoms fall into this category. The rest-about 15%-would not benefit, and there are concerns that FDCT might be slightly less accurate than regular CT in diagnosing these types of strokes. So, we need to test whether One-Stop management is safe and effective for all patients, not just those with treatable blockages.
To do this, the GET-FAST trial will compare the One-Stop approach to the standard two-room process. Patients will be randomly assigned to one of the two strategies. Importantly, this randomization won't affect their actual treatment-everyone will still receive the best care according to current medical guidelines. The main endpoint for the evaluation of the One-Stop approach will be long-term (at 90 days) disability and dependency in daily life as measured with the modified Rankin Scale (mRS).
This study will include all patients as they were assigned, regardless of what type of stroke they actually had. This is called an "intention-to-treat" analysis, and it provides the most reliable measure of the overall impact of One-Stop management.
Another key aspect of the trial is that any CE-certified imaging system already used in hospitals can be used for the One-Stop process-no specific brand or model is required. This makes the results more applicable to real-world hospital settings.
If GET-FAST proves that One-Stop management leads to better patient outcomes, this could transform how stroke care is delivered. More patients could return to independent living, and fewer would require long-term care -leading to major reductions in healthcare costs. For example, even a one-point improvement on a common stroke disability scale (mRS) can triple the savings in lifetime care costs.
- Being tested
- One Stop Management, Usual care management
- Medical subject headings
- Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Stop ManagementOther
Patients within the intervention group will be transported directly after randomization to the angiography room. In the angiography room diagnostic imaging will be performed using cranial non-contrast FDCT and FDCT-A with subsequent EVT (if a treatable vessel occlusion was identified). Therefore, diagnostics and treatment will be performed in the same room (One-Stop management). Only patients with a treatable occlusion will undergo arterial puncture.
Usual care managementOther
Patients within the control group will be transported directly after randomization to the multidetector CT (MDCT) room for diagnostic imaging with non-contrast MDCT and MDCT-A. IVT will be given directly in the MDCT room if no contraindication is present. If on diagnostic imaging a treatable vessel occlusion was identified, the patient will be transported to the angiography room, where EVT will be performed.
| Study group | Role | What they receive |
|---|---|---|
| One Stop Management | Experimental | Patients within the intervention group will be transported directly after randomization to the angiography room. Receives: Other: One Stop Management |
| Usual Care Management | Active comparator | Patients within the control group will be transported directly after randomization to the multidetector CT (MDCT) room for diagnostic imaging with non-contrast MDCT and MDCT-A. Receives: Other: Usual care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Dependency and disability in daily activities
As assessed with the modified Rankin Scale (mRS); The mRS runs from 0-6, running from perfect health without symptoms (0) to death (6).
Measured: 90 days (+/- 15 days) after randomization
Secondary outcomes (8)
Early neurological improvement
Early neurological improvement is defined as a decrease of at least 4 points on the National Institute of Health Stoke Scale (NIHSS) compared to baseline; range of NIHSS 0 - 42 with higher values indicating more severe neurological deficit
Measured: 5 - 7 days after randomization or discharge if earlier
Early neurological deterioration
Early neurological deterioration is defined as an increase of at least 4 points on National Institutes of Health Stroke Scale compared to baseline, death or persistent coma; range of NIHSS 0 - 42 with higher values indicating more severe neurological deficit
Measured: 5 - 7 days after randomization or discharge if earlier
Independent functional outcome
Defined as a modified Rankin Scale of 0 to 2 (mRS); The mRS runs from 0-6, running from perfect health without symptoms (0) to death (6).
Measured: 90 days (+ / - 15 days) after randomization
Cognitive function
As assessed with the Montreal Cognitive Assessment Test (MoCA); range 0 - 30 with lower values indicating more severe cognitive impairment
Measured: 90 days (+/- 15 days) after randomization
Health-related quality of life
As assessed with the Euro-Qol 5d; 5 point scale with higher values indicating better quality of life in the specific domain
Measured: 90 days (+/- 15 days) after randomization
Degree of Dependency and disability in daily activities
As assessed with the modified Rankin Scale (mRS); The mRS runs from 0-6, running from perfect health without symptoms (0) to death (6).
Measured: 365 days (+/- 30 days) after randomization
Health-related quality of life
As assessed with the Euro-QoL-5D; 5 point scale with higher values indicating better quality of life in the specific domain
Measured: 365 days (+/- 30 days) after randomization
Cognitive function
As assessed with the telephone Montreal Cognitive Assessment Test (T-MoCA); range 0 - 22 with lower values indicating more severe cognitive impairment
Measured: 365 days (+/- 30 days) after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start2 Dec 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Jan Liman
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Deutsche Forschungegemeinschaft, Klinikum Nürnberg
- Responsible party
- Sponsor-investigator, Prof. Dr. Jan Liman, Paracelsus Medical University
- Investigators
- Jan Liman, Dr, Principal investigator, Klinkum NurembergMarios Psychogios, Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052045
- Sponsor's protocol ID
- GET-FAST
- Acronym
- GET-FAST
- Status last verified
- Jan 2026
- First submitted
- 26 Jun 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Publications
Psychogios MN, Behme D, Schregel K, Tsogkas I, Maier IL, Leyhe JR, Zapf A, Tran J, Bahr M, Liman J, Knauth M. One-Stop Management of Acute Stroke Patients: Minimizing Door-to-Reperfusion Times. Stroke. 2017 Nov;48(11):3152-3155. doi: 10.1161/STROKEAHA.117.018077. Epub 2017 Oct 10.
PubMed 29018132Psychogios MN, Maier IL, Tsogkas I, Hesse AC, Brehm A, Behme D, Schnieder M, Schregel K, Papageorgiou I, Liebeskind DS, Goyal M, Bahr M, Knauth M, Liman J. One-Stop Management of 230 Consecutive Acute Stroke Patients: Report of Procedural Times and Clinical Outcome. J Clin Med. 2019 Dec 11;8(12):2185. doi: 10.3390/jcm8122185.
PubMed 31835763