Calcium modification during PCI: an algorithmic approach
Research type
Research Study
Full title
Algorithmic approaches to the IVUS-guided treatment of severely calcified coronary lesions during PCI: an observational study
IRAS ID
333036
Contact name
Francis Joshi
Contact email
Sponsor organisation
Golden Jubilee National Hospital
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Bigger, well-expanded stents generally lead to better patient outcomes after stent treatment ("PCI") of the coronary arteries of the heart. The primary barrier to coronary stent expansion is calcification (hardening) of the narrowing (plaque) in the artery. Once implanted and underexpanded, it is very challenging to then achieve better stent expansion. Modification of the plaque prior to stent expansion is considered the optimal approach.
Intravascular imaging with ultrasound is increasingly used in PCI procedures. Plaques are now imaged and classified according to the degree of calcification. There are now several algorithmic approaches to modifying and treating this before stent implantation; none have been evaluated prospectively.
It is not known how often algorithmic approaches achieve optimal expansion as defined by validated criteria from a landmark clinical study called ULTIMATE. Furthermore, the resources in terms of equipment (wires, balloons and other tools) required to achieve good stent expansion using an algorithmic approach to plaque modification have not been documented.
This clinical observational study aims to look at stent expansion and resource use in patients undergoing IVUS-guided PCI for clinical reasons when a typical calcium modification algorithm is used. Following their procedures, patients meeting the inclusion criteria will be asked for consent for anonymised demographic and procedural data to be collected and stored in a password-protected REDCap database based on servers at the University of Glasgow. Final IVUS results will be analysed to assess stent expansion with reference to the validated criteria used in the ULTIMATE study. A list of consumables used during the procedure will be used to measure procedural costs.
REC name
Wales REC 7
REC reference
24/WA/0027
Date of REC Opinion
13 Feb 2024
REC opinion
Further Information Favourable Opinion