One-Stop manaGemEnT For A Swift Initiation of Endovascular Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-02

Study Completion Date

2028-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Acute Acute Ischemic Stroke AIS Hemorrhagic Stroke, Intracerebral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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One Stop Management

Patients within the intervention group will be transported directly after randomization to the angiography room.

Group Type EXPERIMENTAL

One Stop Management

Intervention Type OTHER

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 Management

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.

Group Type ACTIVE_COMPARATOR

Usual care management

Intervention Type OTHER

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.

Interventions

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One Stop Management

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.

Intervention Type OTHER

Usual care management

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No