LOVE DEB
Research type
Research Study
Full title
Large de-NOVo coronary artEry disease treated with sirolimus Drug Eluting Balloon: prospective evaluation of safety & efficacy of SELUTION SLR TM drug eluting balloon (LOVE-DEB Registry)
IRAS ID
313203
Contact name
Abhishek Kumar
Contact email
Sponsor organisation
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 2 days
Research summary
This is a research registry that will monitor the health of patients who have had a PCI performed with a SELUTION SLRTM drug eluting balloon for 12 months. It will be a multicentre registry at up to 10 UK sites including 300 participants. This registry is in patients who have had PCI with the SELUTION SLRTM drug eluting balloon as standard of care practice, this device was approved for this indication 2 years ago and the registry involves no changes to the standard of care treatment that patients would usually get. Patients will only be approached for participation after they have been treated with the device.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/PR/1358
Date of REC Opinion
29 Nov 2022
REC opinion
Further Information Favourable Opinion