Endovascular Therapy for treatment of medium vessel occlusion stroke
Research type
Research Study
Full title
EnDovascular therapy plus best medical treatment (BMT) versus BMT alone for MedIum VeSsel Occlusion sTroke - a prAgmatic, international, multicentre, randomized triaL (DISTAL)
IRAS ID
321329
Contact name
Paul Bhogal
Contact email
Sponsor organisation
University Hospital Basel
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
BACKGROUND
Stroke is the main cause of disability and thereby the third leading cause of loss of quality adjusted life years. In 2015 the widespread implementation of endovascular therapy (EVT) for (non-medium), large vessel occlusions was a game-changer in stroke therapy. This treatment prevents severe disability in more than one out of three patients treated. However, for patients with more distal, medium sized brain vessel occlusions (MeVO) there is no evidence-based treatment besides pharmacological therapy. Almost 20% of all disabling strokes are caused by MeVOs. The prognosis of such occlusions (even with pharmacological therapy) is grim with more than 50% of patients being disabled or dead. There is increasing evidence that also patients who don’t have large but medium vessel occlusions may benefit from EVT. However, there is still substantial uncertainty and large-scale surveys show that despite this promising evidence only 60% of physicians decide in favor of EVT for patients with MeVOs.
AIM
To address this uncertainty, we aim to evaluate the potential benefits of EVT in patients presenting with an acute ischemic stroke due to a MeVO in a randomized clinical trial.
METHODS
DISTAL will be performed as a pragmatic, multicentre, randomized-controlled trial with blinded endpoint assessment. The largest patient interest group for stroke patients in Switzerland acknowledges the relevance of our chosen primary outcome, which will be disability or dependence in daily activities 90 days after stroke. We plan to recruit 526 patients in up to 50 high volume stroke centers over the enrollment period of 36 months.
POTENTIAL SIGNIFICANCE
If the proposed trial proofs the benefit of EVT in this patient group, it is likely that it will influence future decisions regarding standard of care. It would have a substantial impact on the handicap and quality of life of a large group of ischemic stroke patients.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0028
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion