Patients presenting with NSTEMI stable or unstable angina, or silent
Conditions
Interventions
PCI with bioabsorbable scaffold
Sponsors
Investigator Initiated study (Erasmus MC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient presenting with NSTEMI stable or unstable angina , or silent ischemia caused by a de novo stenotic lesion in a native previous untreated coronary artery. 2. Dmax (proximal and distal mean lumen diameter) within the upper limit of 3.8 mm and the lower limit of 2.0 mm by online QCA (at the moment only for the 2.5 mm and 3.5 mm devices)
Exclusion criteria
Exclusion criteria: 1. Previous CABG 2. Cardiogenic shock 3. STEMI patients requiring immediate stent implantation 4. Bifurcation lesion requiring kissing ballon postdilatation 5. Allergies or contraindications to antiplatelet medication 6. Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding 7. Expected survival of < 1year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE): defined as cardiac death, re-MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 12 months post-procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Major Adverse Cardiac Events (MACE): defined as cardiac death, re-MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods 30 days, 6, 12, 18 months, 2, 3, 4, and 5 years post-procedure 2. Target vessel failure (TVF) defined as cardiac death, target vessel myocardial infarction (MI) [Q or Non Q-Wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods at 30 days, 6, 12, 18 months, 2, 4 and 5 years. 3. Health Related Quality-of-Life (HRQL) at 30 days, 6, 12 months, 3 and 5 years 4. Success Rates: a) Device Success: Attainment of <30% final residual stenosis of the segment of the culprit lesion covered by the BVS, by visual estimation b) Procedure Success: Device success and no peri-procedural complications c) Clinical success: Procedural success and no in-hospital MACE 5. Reperfusion measured by: TIMI Flow: TIMI flow at the end of the procedure 6. Incidence of stroke at 30 days, 6, 12, 18 months, 2, 3, 4, and 5 years 7. Stent thrombosis at 30 days, 6, 12, 18 months, 2, 3, 4, and 5 years 8. Vessel geometry of treated segments at 18 months FU MSCT | — |
Contacts
Public ContactA. Ruiter
Afd Cardiologie (Trialbureau) Erasmus MC, Postbus 2040
Outcome results
None listed