Acute Coronary Syndrome
Conditions
Interventions
See also page 28 (section 10.3) of the protocol:
10.3. Stenting Procedure
10.3.1. Baseline Angiography
Baseline angiography of the target vessel will be completed as per the
Angiographic Core Labor
Sponsors
OrbusNeich Medical B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: See page 23 (Sec. 9.4.1) of the protocol:;9.4.1 Inclusion Criteria Patients must meet ALL of the following criteria:;General Inclusion Criteria: 1. The patient must be *18 and * 80 years of age;;2. ST or Non-ST-segment elevation myocardial infarction (STEMI or NSTEMI) (assumed - by the investigator - to be a type 1 myocardial infarction, according to universal definition of MI; Eur Heart J. 2007; 28(20):2525-38) (1);;3. Acceptable candidate for CABG;;4. The Patient is willing to comply with specified follow-up evaluations;;5. 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).;Angiographic Inclusion criteria: 6. Single de novo or non-stented restenotic lesion in a native coronary artery;;7. Patients with two-vessel coronary disease, may have undergone successful treatment (
Exclusion criteria
Exclusion criteria: See page 23 (Sec. 9.4.2) of the protocol:;9.4.2. Exclusion Criteria Patients will be excluded if ANY of the following conditions apply: ;General 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 WBC50%) stenosis proximal or distal to the target lesion that cannot be covered by same single stent;;21. Diffuse distal disease to target lesion with impaired runoff;;22. Pre-treatment with devices other than balloon angioplasty;;23. Prior stent within 10 mm of target lesion;;24. Intervention (PCI or bypass) of any lesion in the target vessel performed within the previous 6 months;;25. Intervention (PCI or bypass) of another lesion in a non-target vessel performed within 30 days prior to the index procedure;;26. planned intervention of another lesion (target vessel or non-target vessel) within 30 days following the index procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| See also page 20 (section 8.1) of the protocol: 8.1. Primary Endpoint Percentage of uncovered stent struts per stent at 60 days follow-up (by OCT) | — |
Secondary
| Measure | Time frame |
|---|---|
| See also page 20 (section 8.2-8.3) of the protocol: 8.2. Secondary OCT Endpoints * Percentage of stent strut malapposition * Maximum length of segments (mm) with uncovered struts * Maximum length of segments (mm) with malapposed struts * Maximum malapposition distance (mm) * Total malapposition volume * Maximal malapposition volume * Mean neointimal thickeness (strut level) * Percentage of protruding struts per stent * Frequency of Abnormal Intrastent Tissue (AIST) * Stent Volume * Lumen Volume * NIH Volume OCT Indices * NHI (Neointima heterogeneity index) - ratio of maximum neointimal thickness to the average neointimal thickness in each frame. * RUTTS-OCT (Rate of Uncovered To Total Struts in the frame by OCT) Index - The number of sub segments of 2.5mm with uncovered strut/ total number of struts per sub segment (continuous variable and stratified by thresholds >10%, >20%, >30%). * PFU (Percentage of Frames with Uncovered struts) index - the percentage of frames with any uncovered struts per cross-section. * PFM (Percentage of Frames with Malapposition struts) index - the percentage of frames with any malapposition struts per cross-section Quantitative characterization of NIH tissue * Mean Attenuation * Mean Backscatter * Normalized Standard Deviation * Mean Intensity * * width (distance from peak intensity to its half intensity Additional variables (baseline and/or post procedure) * Rates of late acquired stent strut malapposition (matched, FUP vs POST) * Percentage of embedded struts post-procedure * Dissection post procedure behind the stent * Dissection post procedure at stent edges (length, depth) * Qualitative plaque characterization (pre procedure or non-stented segment post procedure) Secondary Clinical Endpoints * Major Adverse Cardiac Events defined as a composite of death, MI (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or justified target lesion revascularization (TLR) by repeat PTCA | — |
Countries
Netherlands
Outcome results
None listed