The TENSION research project is to conduct a clinical study to show whether patients affected by severe strokes can also benefit from the mechanical thrombectomy. The study is starting at 40 sites in eight countries in close cooperation with the University Hospital of Heidelberg. It is supported by €6.5 million from the European Union.
A large percentage of strokes in Europe are caused by a blood clot that closes a blood vessel in the brain so that parts of the brain can no longer be supplied with oxygen. Previously, if only a small amount of brain tissue was damaged, doctors could insert a catheter into the arteries of the brain from the groin under X-ray control and remove the clot with special instruments. It is currently unclear whether this treatment will also help patients with major stroke.
“With our research project TENSION we want to analyse if patients with already extensive cerebral infarcts can also benefit from a thrombectomy as well,” says Laurent Pierot, President of ESMINT and Director of the Department of Neuroradiology in Reims, France. “If our assumptions were confirmed, this would result in an effective treatment approach for stroke patients who have been seriously affected.”
Up to 714 patients who are admitted with a stroke at one of the 40 sites throughout Europe are to be included in the study. “In order to ensure a uniform highest quality of procedural quality in all study centres, we have developed a standardised training and accreditation programme,” says Patrick Brouwer, General Secretary of ESMINT and senior consultant at the Karolinska Hospital in Stockholm.
Patients are randomly divided into two groups: While the first group receives conventional drug therapy, in the second group the clot is additionally removed by thrombectomy. After 90 days, the degree of the patient’s disability due to the stroke is recorded on the basis of a scale customary in stroke treatment.
The clinical study is coordinated from Heidelberg University Hospital, Germany and the TENSION research project is managed by the UKE.