Coronary Artery Disease
Conditions
Interventions
COMBO stent placement
Sponsors
Orbus Neich
Eligibility
Inclusion criteria
Inclusion criteria: • Subject has a bifurcation lesion involving a side-branch larger than 2 mm (after pre-dilatation) and having main branch involvement (Medina 0,0,1 lesions are excluded) • Subject must agree to undergo all clinical investigation plan-required follow-up visits • 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: 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 stent strategy is planned. o Subject has known hypersensitivity or contraindication to contrast, 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 judgment, e.g., subordinate hospital staff) or subject unable to read or write.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Appearance of overhanging struts in front of the side branch ostium on three-dimensional OCT post-implantation and post-procedure measured by cute-plane analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of non-apposed side branch (NASB) struts post-implantation and post-procedure | — |
Contacts
Public ContactLaura Kerkmeijer
Amsterdam UMC, location AMC
Outcome results
None listed