coronary artery disease
Conditions
Interventions
A total of 117 patients will undergo treatment with implantation of the MeRes100 BRS with protocolized PSP method and intracoronary imaging guidance. 
Sponsors
Caredo BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Stable coronary artery disease with one or more significant epicardial stenosis in native coronary arteries Subject must be at least 18 years of ageWritten consent to participate in the study
Exclusion criteria
Exclusion criteria: 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. Bifurcation lesions. Ostial lesions. Lesions with a difference in proximal and distal reference diameter of >0.5 mm by visual judgement of the coronary angiogram by the treating operator. Treatment of in-stent restenosis or stent thrombosis. History of definite stent thrombosis. Lesions in coronary artery bypass grafts.Lesions not suitable for OCT or IVUS catheter delivery and imaging, e.g. due to tortuosity or distal localisation. Creatinine Clearance = 30 ml/min/1.73 m2 as calculated by MDRD formula for estimated GFR.Contraindication to dual antiplatelet therapy with aspirin and a P2Y12 inhibitor or (if indicated) NOAC and P2Y12 inhibitor.Planned non-deferrable major surgery after PCI.Known comorbidity associated with a life expectancy <1 year.Unable to understand and follow study-related instructions or unable to comply with study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility aspects include percentage of technical success, percentage of angiographic success, percentage of treatment protocol adherence, percentage of optimal and acceptable scaffold result on intracoronary imaging, percentage of additional optimization steps to achieve optimal scaffold result and an estimate of target lesion failure (TLF) and scaffold thrombosis at 1-year and 3-years. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary intracoronary imaging endpoints will be assessed with the final OCT or IVUS measurement:Minimal scaffold area.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).Scaffold expansion as percentage, defined as scaffold area divided by the average of proximal and distal reference lumen areas.Presence of edge dissectionIntra-scaffold plaque protrusion and thrombus, defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut. The following secondary clinical endpoints will be assessed:All-cause mortality.Target Vessel Failure (TVF), defined as cardiovascular death, target-vessel myocardial infarction and clinically indicated target vessel revascularizationMajor Adverse Cardiac Events (MACE), defined as cardiovascular death, target-vessel myocardial infarction and clinically indicated target vessel revascularizationStent thrombosis (definite or probable according to ARC definition).The percentage of post-PCI intracoronary imaging-guided scaffold result optimalization, defined as the composite of all additional post-dilatation and/or additional BRS/DES implantations after post-PCI intracoronary imaging. | — |
Countries
Netherlands
Contacts
Public ContactJ.M. Cheng
Albert Schweitzer Ziekenhuis
Outcome results
None listed