incidence of intracoronary thrombi and late loss neointimal morphology Strut coverage (binary and thickness) strut malapposition
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The patient must be *18 and * 80 years of age; 2. Device and procedural success at the index procedure; 3. The Patient is willing to comply with specified follow-up evaluations; 4. The Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC).
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test; 2. Impaired renal function (serum creatinine >2.0 mg/dL or 177 *mol/l) or on dialysis; 3. Platelet count 700,000 cells/mm3 or a WBC1 overlapping Combo stent at the index procedure; 15. Patient with unsuitable anatomy for OCT (tortious, heavily calcified, small distal stent).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For all analyses the findings at each individual timepoint and the * between timepoints will be assesed - OCT findings on strut coverage (binary and thickness), neointimal morphology, strut malapposition, incidence of intracoronary thrombi and late loss (late tissue growth, plaque volume, lumen cross sectional area). - Quantitative Coronary Angiography analyses of minimal lumen diameter, mean lumen diameter, maximum percent stenosis, mean stenosis and late lumen loss. | — |
Countries
Netherlands
Outcome results
None listed