Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07052045

One-Stop manaGemEnT For A Swift Initiation of Endovascular Therapy

Led by Prof. Dr. Jan Liman · Updated on 2026-01-20

390

Participants Needed

2

Research Sites

152 weeks

Total Duration

On this page

Sponsors

P

Prof. Dr. Jan Liman

Lead Sponsor

U

University Hospital, Basel, Switzerland

Collaborating Sponsor

AI-Summary

What this Trial Is About

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. 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.

CONDITIONS

Official Title

One-Stop manaGemEnT For A Swift Initiation of Endovascular Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptoms suggestive of acute ischemic stroke caused by a large or medium vessel blockage with NIH Stroke Scale score of 10 or more
  • Patient arrives directly to the treating hospital within 4.5 hours of last seen well
  • Age 18 years or older
  • Independent in daily activities before the stroke (modified Rankin Scale 0 to 2)
  • Endovascular treatment team available including neurologist, interventionist, anesthesiologist, nursing, and technicians
  • Informed consent obtained or emergency consent procedures fulfilled
Not Eligible

You will not qualify if you...

  • Severe other health conditions likely preventing improvement or follow-up
  • Stroke occurring while already in the hospital
  • Symptoms suggesting brain bleeding (worsening during transport, vomiting, or decreased consciousness)
  • Strong suspicion of functional neurological symptom disorder or conversion disorder
  • Unstable patients needing advanced vital support
  • Angiography room is occupied by another procedure

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Klinik für Neurologie, Universitätsklinik der Paracelsus

Nuremberg, Germany, 90471

Actively Recruiting

2

University Hospital Basel

Basel, Switzerland, 4031

Not Yet Recruiting

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Research Team

A

Alex Brehm, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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