Selution DeNovo: Open Label Selution DEB strategy versus DES strategy
Research type
Research Study
Full title
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
IRAS ID
298927
Contact name
Peter O'Kane
Contact email
peter.o'kane@uhd.nhs.uk
Sponsor organisation
Med Alliance SA
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 10 days
Research summary
This study is a multi-centre, open label, clinical trial. It will assess treatment of the narrowing of the heart blood vessels by examining if treatment strategy with a drug coated balloon (DCB) is as good as treatment strategy a drug eluting stent (DES). Ultimately, after 5 years it will also test if treatment strategy with the DCB is even better than treatment strategy with DES. The surface of the balloon is coated with a drug called sirolimus, that will be released over time (up to 90 days). Sirolimus is used to prevent thickening of the blood vessel wall and to prevent the blood vessel narrowing again after it has been opened by the balloon. Patient will receive randomised treatment and then be followed up for 5 years.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0210
Date of REC Opinion
19 Oct 2021
REC opinion
Further Information Favourable Opinion