CONSISTENT CTO
Research type
Research Study
Full title
CONSISTENT CTO Study An observational study of clinical outcomes after treatment with the Synergy stent in patients with ischaemic heart disease and a chronic total occlusion in a coronary artery.
IRAS ID
155739
Contact name
Simon Walsh
Contact email
Sponsor organisation
CERIC SARL
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 17 days
Research summary
The study population is composed by 215 consecutive patients undergoing treatment of completely blocked coronary arteries (chronic total occlusion or CTO) by a stenting procedure (percutaneous coronary intervention or PCI) with successful reopening of the target vessel and implantation of Synergy drug eluting stents (DES).
The total duration for each subject is 24 months.
All enrolled subjects will be evaluated at 6 months, 12 months, and 2 years. All protocol required follow-up assessments must be conducted with direct contact with the subjects.
An office visit is required for the 12 month follow-up. All other protocol-required follow-up assessments may be performed via telephone interview or office visit as per local practice and subjects’ mobility. All subjects will undergo angiographic and OCT follow-up during the 12-month follow-up visit.REC name
HSC REC A
REC reference
14/NI/1113
Date of REC Opinion
6 Nov 2014
REC opinion
Further Information Favourable Opinion