Coronary Artery Disease Coronary Atherosclerosis
Conditions
Interventions
lntervention of interest is either fenestration or no fenestration of the stent
towards the sidebranch.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: o Subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (Medina 0,0,1 lesions are excluded) o Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography o Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure,as approved by the appropriate Ethics Committee.
Exclusion criteria
Exclusion criteria: o Subject is younger than 18 years of age o Subject is presenting with a STEMI o Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned. o Subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. o Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) 2.5mg/dL or subject on dialysis) o Subject with a limited life expectancy less than one year. o Subject is belonging to a vulnerable population (per investigator*s , e.g., subordinate hospital staff) or subject unable to read or write.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| nvt | — |
Primary
| Measure | Time frame |
|---|---|
| OCT endpoints o Incomplete strut apposition in the bifurcation region at baseline, at 12 months, 24 months and 36 months o Number of embedded and protruded struts per region at baseline, 12, 24 months and 36 months o Incomplete strut coverage in the bifurcation region at 12, 24 months and 36 months o Number of non-apposed side branch (NASB) struts at baseline at 12, 24 months and 36 months o Tissue in-between NASB struts at 12 and 36 months o Appearance of jailed side branch struts on three-dimensional OCT at baseline, 12, 24 months and 36 months including the V, T, H, double V, double T and double H shapes. o Mean/Minimal Scaffold diameter/area at baseline, 12, 24 months and 36 months o Mean/Minimal Lumen diameter/area at baseline, 12, 24 months and 36 months o Neointima thickness at 12 and 36 months; in total and per segment (proximal end distal main branch; bifurcation region). o Scaffold pattern irregularities at baseline, 12, 24 months and 36 months o Incomplete strut apposition in the bifurcation region at baseline, 12 months, 24 months and 36 months between re-crossing through the distal compartment and other compartments. o Number of non-apposed side branch (NASB) struts at baseline 12 months, 24 months and 36 months between re-crossing through the distal compartment and other compartments. o Appearance of jailed side branch struts on three-dimensional OCT at baseline 12 months, 24 months and 36 months including the V, T, H, double V, double T and double H shape between re-crossing through the distal compartment and other compartments. Angiographic endpoints o Proximal 5mm SB% diameter stenosis (DS) postnitrate at baseline, 12, 24 months and 36 months o In-segment Late Loss (LL) postnitrate at 12 months, 24 months and at 36 months o Proximal LL postnitrate at 12 months, 24 months and at 36 months o Distal LL postnitrate at 12 months, 24 months and at 36 months o In-scaffold/in-stent, in-segment, proximal and distal MLD post | — |
Countries
Netherlands
Outcome results
None listed