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.
Study Type
OBSERVATIONAL
Enrollment
117
Percutaneous coronary intervention (PCI) with implantation of the MeRes100 thin-strut BRS with protocolized PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance.
Albert Schweitzer ziekenhuis
Dordrecht, Netherlands
RECRUITINGTechnical success
Percentage of technical success, defined as successful implantation of the BRS in the obstructive coronary lesion.
Time frame: End of procedure
Angiographic success
Percentage of angiographic success, defined as \<10% residual stenosis and TIMI 3 flow.
Time frame: End of procedure
Treatment protocol adherence
Percentage of treatment protocol adherence, defined as full completion of all PSP and intracoronary imaging steps during implantation procedure.
Time frame: End of 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%.
Time frame: End of procedure
Additional optimization steps
Percentage of additional optimization steps (including additional postdilatation, additional BRS implantation, bailout metallic DES implantation, additional intracoronary imaging) to achieve optimal scaffold result.
Time frame: End of procedure
Target Lesion Failure
Estimate of target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization
Time frame: 1-year and 3-year post-procedure
Scaffold thrombosis
Estimate of scaffold thrombosis
Time frame: 1-year and 3-year post-procedure
Minimal scaffold area
Minimal scaffold area assessed with the final OCT or IVUS measurement
Time frame: End of procedure
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.
Time frame: End of procedure
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.
Time frame: End of procedure
Edge dissection
Presence of edge dissection assessed with the final OCT or IVUS measurement.
Time frame: End of procedure
Intra-scaffold plaque protrusion and thrombus
Intra-scaffold plaque protrusion and thrombus, defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut, assessed with the final OCT or IVUS measurement.
Time frame: End of procedure
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