Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT

All stented coronary artery patients hospitalised for stable angina or an ACS requiring a further coronary angiogram (regardless of time since implantation or type of the initial stent) identified to have intrastent restenosis during coronary angiography will be included after being informed and obtaining their informed written consent.

• For cases of stable angina the OCT the will be performed immediately with insertion of the probe distal to the area being studied and then automatic retraction of the fibre during injection of the contrast medium.
• For ACS, the OCT will be performed immediately or on a deferred basis at the discretion of the operator.
• For critical lesions which prevent the OCT fibre passing across the lesion, "soft" predilatation with a 2 mm or smaller balloon is permitted.
• Practical conduct of the OCT:

• Pullback at baseline state and analysis of the stent with a 5 mm margin proximal and distal to the lesion.
• OCT analysis: under-deployment of the stent (expansion < 80% of the reference mean surface area), neoatherosclerosis with or without rupture, homogeneous or non-homogeneous hyperplasia, stent fracture and proximal or distal progression of the atherosclerosis.
• Final pullback in cases of a new angioplasty (balloon angioplasty, angioplasty with a coated balloon or stenting).
• The OCT investigations will be anonymised and registered in their original format with a view to centralised reading (Corelab ISIT, UMR 6284-CNRS, Clermont-Ferrand University).
• The angiography records will be submitted for reading by a panel blinded to the OCT for the purposes of demonstrating the added value of OCT in the fine details of diagnosis and the impact of a treatment decision. The angiograms will be reviewed in a centralised analytical laboratory, which will re-read the procedures blind.
• Patients will be followed up via telephone contact or visit one year after inclusion into the study to record any complications which have developed (possible myocardial infarction, reason, any new revascularisation of the target lesion or another artery and reason for this, any deaths and their causes).

Inclusion criteria

• Men or women, aged 18 years and over.
• Uncoated, coated or bioresorbable stent restenosis, defined by lumen obstruction of over 50% in the stent and/or within 5 mm proximal or distal to the stent found on coronary angiography.
• Patients treated for an acute coronary syndrome in which restenosis is suspected. It is recommended that OCT be performed after restoring TIMI grade 3 coronary flow in the initial investigation or in a later review at < 7 days.
• Patient informed consent.
• Subscription to a social security system.

Exclusion criteria

• Technical inability to perform the OCT (distal lesions, severe chronic renal failure).
• Contraindication to the use of ABBOTT systems when insertion of any type of catheter represents a risk to the patient. The contraindications include the following:

• Bacteraemia or septicaemia
• Significant coagulation system abnormalities
• Patients in whom coronary artery spasm has been diagnosed
• Patients who do not meet the criteria for coronary artery bypass grafting
• Patients who do not meet the criteria for percutaneous coronary angioplasty
• Severe haemodynamic shock or instability
• Total occlusion
• Life expectancy of under one year for non-cardiac reasons.
• Pregnant or breast-feeding women or women who are fertile and not taking appropriate contraceptives.
• Patients under legal protection or guardianship