About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging
Treatment groups
Sponsors and collaborators
Albert Schweitzer Ziekenhuis, Netherlands
Lead sponsor
Meril Life Sciences Pvt. Ltd.
Collaborator
Angiocare BV, Netherlands
Collaborator
Salveo Medical BV, Netherlands
Collaborator