Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic local inflammation which may lead to in-stent restenosis, absence of physiological coronary vasomotion and vessel caging which makes future coronary artery bypass grafting (CABG) impossible. A bioresorbable scaffold (BRS) is designed to overcome these limitations. The first generation BRS was shown to be clinically inferior to DES due to a slightly higher rate of stent thrombosis. To overcome this problem, several scientific developments have been achieved in the past few years, such as thinner BRS strut construction and improved implantation technique by using PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). A PCI protocol that combines implantation of a second generation thin-strut BRS, mandatory PSP implantation method and mandatory intracoronary imaging-guidance has not yet been investigated. The aim of this study is to investigate feasibility of a new PCI protocol with implantation of the second generation Meres100 thin-strut BRS combined with a protocolized PSP implantation technique guided by intracoronary imaging.
Stable coronary artery disease with one or more significant epicardial stenosis in native coronary arteries suitable for OCT or IVUS-guided PCI with BRS implantation.
Subject must be at least 18 years of age
Written consent to participate in the study
Culprit lesions in the setting of acute coronary syndrome.
Lesions with severe calcification.
Lesions in a coronary artery with severe tortuosity.
Left main coronary artery lesions.
Patients with obstructive stable coronary artery disease
Cohort
Prospective
Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging
Procedure/SurgeryPercutaneous coronary intervention (PCI) with implantation of the MeRes100 thin-strut BRS with protocolized PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance.
Technical success
Percentage of technical success, defined as successful implantation of the BRS in the obstructive coronary lesion.
Angiographic success
Percentage of angiographic success, defined as \<10% residual stenosis and TIMI 3 flow.
Treatment protocol adherence
Percentage of treatment protocol adherence, defined as full completion of all PSP and intracoronary imaging steps during implantation procedure.
Optimal scaffold result
Percentage of optimal scaffold result on intracoronary imaging, defined as no major edge dissection, no major malexpansion and scaffold expansion \>90%.
Minimal scaffold area
Minimal scaffold area assessed with the final OCT or IVUS measurement
Scaffold malapposition
Scaffold malapposition as percentage, defined as frequency of incompletely apposed struts (i.e. struts clearly separated from the vessel wall without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch) assessed with the final OCT or IVUS measurement.
Scaffold expansion
Scaffold expansion as percentage, defined as scaffold area divided by the average of proximal and distal reference lumen areas, assessed with the final OCT or IVUS measurement.
Edge dissection
Presence of edge dissection assessed with the final OCT or IVUS measurement.
Click on the lead sponsor to view all of their trials.
Albert Schweitzer Ziekenhuis, Netherlands
Lead sponsor
Meril Life Sciences Pvt. Ltd.
Collaborator
Angiocare BV, Netherlands
Collaborator
Salveo Medical BV, Netherlands
Collaborator
