Atherosclerosis, vulnerable plaque atherosclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for the main trial: - Informed consent must be obtained. - Patients are hospitalized with a STEMI or NSTEMI (or have been in the last 6 weeks), for which they are subjected to invasive coronary angiography. - Invasive coronary angiography shows residual non-culprit CAD (target lesion(s)) - Patient has >= 1 target lesion(s) on angiography with following additional characteristics: - Lesion has visual stenosis of 30-90%. - Lesion is non-obstructive (FFR>0.80). - Lesion is not in-stent restenosis. Inclusion criteria for the registry: Inclusion criteria for the registry are the same as for the main trial, except: - All target lesions are obstructive (FFR
Exclusion criteria
Exclusion criteria: - Refusal or inability to provide informed consent. - = 3 at time of inclusion. - Previous CABG. - Indication for revascularization by CABG. - Anatomy of target lesion(s) unsuitable for OCT catheter crossing or imaging (aorta-ostial lesions, too small diameter segment, severe calcifications, chronic total occlusion, lesions located to distally) - Pregnancy. - Estimated life expectancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The primary outcome at 1 and 5 year follow-up. Also target lesion/vessel failure and target lesion/vessel revascularisation at 1,2, and 5 years. | — |
Primary
| Measure | Time frame |
|---|---|
| A composite of major adverse cardiovascular events (all-cause mortality, non-fatal myocardial infarction (STEMI or NSTEMI), or unplanned revascularization) at 2 year follow-up. | — |
Countries
Aruba, Estonia, Netherlands, Russian Federation
Contacts
Radboud Universitair Medisch Centrum