Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke (SWIFT DIRECT)

Background

The SWIFT DIRECT trial investigates the emergency treatment of patients with an acute ischaemic stroke. An ischaemic stroke is caused by the blockage of one or more blood vessels in the brain. A clot blocks the blood vessels and blood can no longer circulate. This results in an undersupply of blood and oxygen to the brain regions supplied by these vessels. If the under-supply lasts longer than a few minutes, there is a risk that nerve cells might die. An ischaemic cerebral infarction is a life-threatening situation.

For years, the only causal treatment was the administration of a clot-lysing drug called tissue plasminogen activator. The drug, however, may induce bleedings and is not sufficiently effective in patients with very large clots. In 2014, a new treatment, the so-called mechanical thrombectomy, has been established. With this therapy, nearly all types of large blood clots can directly be removed from the vessel using a specialized catheter. Trials have shown that patients treated with tissue plasminogen activator and mechanical thrombectomy have better outcomes than patients treated with tissue plasminogen activator only. Hence, the current standard treatment in patients with large clots is administration of tissue plasminogen activator followed by mechanical thrombectomy.

As administration of tissue plasminogen activator may also harm the patient and is not effective in patients with large clots, we want to investigate how potent direct mechanical thrombectomy (without prior administration of tissue plasminogen activator) is. The purpose of this trial is thus to compare direct removal of the clot with mechanical thrombectomy versus tissue plasminogen activator administration followed by removal of the clot with mechanical thrombectomy. Only patients with large clots and direct access to mechanical thrombectomy can be included in the trial.

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We are conducting this trial to improve the emergency treatment for affected patients with an acute ischaemic stroke. This project is organised by the Neuro Clinical Trial Unit at the University of Bern, Switzerland and will be carried out at several hospitals in Europe and Canada.

What does it mean for patients to participate in this clinical trial?

Trial participants will be assigned by chance to one of two groups (half of the patients will be in each group). In the ‘treatment group’ the blood clot is removed directly with mechanical thrombectomy. In the ‘standard group’, participants first receive blood clot-dissolving medication followed by mechanical thrombectomy to remove the clot.

Both treatment options are commonly used standard treatments. The choice between the two is part of clinical routine at the hospital and lies upon the judgement of the treating physician. Except for the phone interview 90 days after the infarction incident, all examinations are part of standard treatment routine independent from the trial.

General information about the trial

Study type: Multicenter, prospective, randomized, open label, blinded endpoint (PROBE) trial
Trial start and end: October 2017 to December 2020
Sponsor-Investigators: Prof. Dr. med. Urs Fischer, Neurology, and

Prof. Dr. med. Jan Gralla, Neuroradiology,

University Hospital Bern, Inselspital, Switzerland

Total number of participants: 404 patients
Trial duration for each participant: 3 months
Participating countries: Austria, Canada, Finland, France, Germany, Spain and Switzerland
Financial support: Medtronic (Minneapolis, USA)
Trial registration: www.clinicaltrials.gov, No.: NCT03192332

Please visit the website www.swift-direct.com for further information.

This trial is endorsed by SAFE.