Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study (Integration-II)
Ischaemic Heart Disease
About this trial
This is an interventional treatment trial for Ischaemic Heart Disease focused on measuring OCT, Co-Registration, Stent, PCI, Geographical mismatch, Edge Dissection
Eligibility Criteria
Inclusion Criteria:
- Patient with indication for coronary angiography for angina (stable or unstable), silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive invasive or non-invasive test must be present), or NSTE-ACS
- male or non pregnant female patient
- Signed written informed consent
Exclusion Criteria:
- Known neoplasia on treatment / without a curative therapeutic approach
- Presence of one or more co-morbidities which reduces life expectancy to less than 24 months
- Estimated creatinine clearance <40 ml/min
- Cardiogenic shock
- Hemodynamic instability because of arrhythmia
- Known left ventricular ejection fraction (LVEF) <30%.
- Therapy requiring psychiatric disorder
- Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
- Women who are pregnant or breastfeeding
- Refusal of study participation
Sites / Locations
- Charité - Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
Blinded-group
OCT-group
ACR-group
Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators only based on angiographic lesion evaluation (standard care)
Patients underwent OCT-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on OCT findings
Patients underwent ACR-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on ACR-findings