DCBNORWICH
Research type
Research Study
Full title
Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience from 2009 to 2015.
IRAS ID
195002
Contact name
Simon Eccleshall
Contact email
Sponsor organisation
Norfolk and Norwich University Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
195002 , IRAS
Duration of Study in the UK
9 years, 8 months, 22 days
Research summary
We expect to assess outcomes of all patients who received Drug Coated Balloon Angioplasty treatment, which is a novel therapy as opposed to standard Drug Eluting Stent insertion, for all types of coronary artery disease from 01/01/2009 till 31/12/2015 in our centre. We believe the number exceeds 1000 patients.
We plan to collect demographic and procedural data from our existing data base. We will request up to date follow up events from NICOR (National Institute for Cardiovascular Outcomes Research) in 2017(data ending December 2016), by which time all our patients would have had minimum of 12 months follow up. We plan to incorporate these findings to our data set and report the comprehensive outcomes. We also have a long term plan of requesting follow up events from NICOR for up to 10 years, so we can report on long term outcomes of drug coated balloon treatment. We will also assess the patients treated with a drug eluting stent in our institution (approximately 3000 patients from 2009 till 2015). That will allow us to compare the outcomes of the two groups which will increase significantly the scientific value of our study.REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0278
Date of REC Opinion
4 May 2017
REC opinion
Favourable Opinion