(duplicate) The SITS Open - Artery by thrombectomy in acute occlusive
Research type
Research Study
Full title
An international, multicentre controlled study of safety and efficacy of thrombectomy in acute occlusive stroke
IRAS ID
158452
Contact name
Matthew R Walters
Contact email
Sponsor organisation
NHS GG&C
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Intravenous thrombolysis is an effective treatment for acute ischemic stroke in patients where treatment is administered within 4.5 hours of onset after neurological symptoms. However, new data suggest that blood clots that are 6-8 mm or longer cannot be dissolved through intravenous therapy. In cases where thrombolytic therapy is insufficient, a new technique has been developed in recent years that involve the insertion of an instrument into the arterial system up to the site of the blood clot and removing it mechanically, known as mechanical thrombectomy. This development has been made possible by recent technological advances that have significantly improved radiographic methods to quickly locate blood clots and ascertain their effects on cerebral blood flow, primarily using computed tomography technology. It is possible to see within a few minutes exactly where the clot is located and to determine its size. Mechanical thrombectomy is currently routine treatment in many countries, although not all hospitals can offer such highly specialised care.
Thrombectomy is not an evidence-based treatment and some countries and hospitals have chosen not to perform thrombectomies pending clinical studies to provide evidence of benefit. Randomised controlled studies demonstrating benefit have been requested, but the problem is that many of the clinics that have the greatest experience with the procedure are also most reluctant to randomise patients with severe occlusions to no treatment. This study is designed to provide the highest level of evidence for mechanical thrombectomy without randomisation by directly comparing treatment outcomes for patients in hospitals that are able to perform thrombectomy with those from hospitals where the only treatment option is intravenous thrombolysis. Evaluation of treatment outcomes will be blinded and carried out by independent laboratories and clinics. The final statistical analysis involves matching techniques to optimise comparability of treatment options. All matching will be carried out blinded for outcome variables and based solely on baseline data and demographic conditions.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0074
Date of REC Opinion
18 Jun 2015
REC opinion
Further Information Favourable Opinion