angina pectoris coronary sclerosis
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is at least 18 years of age. 2. Patient is know with diabetes mellitus 3. 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 4. 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) 5. The patient understands and accepts the meaning and the aims of the study 6. The patient is willing to comply with specified follow-up evaluation and can be contacted by telephone (Signed Informed Consent)
Exclusion criteria
Exclusion criteria: 1. Previous CABG 2. Cardiogenic shock 3. STEMI patients requiring immediate stent implantation 4. Bifurcation lesion requiring kissing balloon postdilatation 5. Allergies or contraindications to antiplatelet medication or contrast material 6. Female patient with child bearing potential not taking adequate contraceptives or currently breasfeeding 7. Expected survival of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the evaluation of the scaffold coverage at 6-month follow-up by invasive coronary imaging with Optical Coherence Tomography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of the present investigation include OCT, QCA, NIRS imaging (baseline and 6 month) and clinical endpoints (until 5 years follow-up) | — |
Countries
Netherlands
Outcome results
None listed