Optical Coherence Tomography Guided Percutaneous Coronary Intervention With Stent Implantation (OCTACS)
Coronary Artery Disease, Myocardial Infarction
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring PCI optimization, Coronary Remodeling, Drug-Eluting Stent, Optical Coherence Tomography, Intravascular Ultrasound, Strut Coverage, Strut Apposition, Vascular Healing Pattern
Eligibility Criteria
Inclusion Criteria:
- A Non ST segment Elevation Myocardial Infarction (NSTEMI) had been diagnosed
- A de novo lesion (more than or equal to 50% dimater stenosis) had been visualized on coronary angiography
- A Percutaneous Coronary Intervention with Drug-Eluting Stent (DES) implantation was indicated
Exclusion Criteria:
- Patients included in other randomized trials
- Lifeexpectancy <1 year
- Allergy to aspirin, clopidogrel, ticagrelor and prasugrel
- Allergy to limus-agents
- Ostial lesions (not possible to flush by OCT)
- S-creatinin >170 micrograms/l
- Tortuous and extremely calcified lesions where intravascular imaging is deemed associated with an increased risk for the patient
- Very long lesions (due to the limited pullback length of the OCT system)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Angio-guided PCI
OCT-guided PCI
Patients allocated to "angio-guided PCI" are having Percutaneous Coronary Intervention (PCI) with stent implantation guided by routine angiography alone. Documentary (comparator) intravascular imaging with Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) is performed. The PCI-operator is blinded to the image aquisitions, and the analysis is performed offline later.
After obtaining an angiographic optimal result, patients allocated to "OCT-guided PCI" have guiding Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) performed. Online image interpretation is performed by a dedicated OCT-analyst and the PCI-operator. If the OCT reveals; 1) under expansion of the stent with a minimal stent area (MSA) <90% of the distal/proximal reference vessel lumen area and/or; 2) significant acute incomplete stent apposition (defined as more than or equal to 3 stent struts detached >140 microns from the underlying vessel wall), and/or; 3) edge dissection(s) causing significant reduction in minimal lumen area(s) (MLA <4 mm2) and/or, 4) significant residual stenosis (MLA <4 mm2) at the proximal and/or distal reference segment(s), additional intervention is encouraged. The degree of optimization based upon OCT findings is left to the judgement of the PCI-operator.