stable coronary artery disease and non-ST ACS stable coronary artery disease and instable coronary artery disease
Conditions
Interventions
Patients will be treated in a single arm fashion with:
• Complete revascularization with PCI in all vessels >= 2.5 mm with >=70%
stenosis by visual estimation or positive functional assessment and re
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years,
Exclusion criteria
Exclusion criteria: 1. Age 85 years. 2. Single coronary vessel disease. 3. No left anterior descending lesion. 4. Patients in cardiogenic shock. 5. Patients with STEMI. 6. Presence of a chronic total occlusion (CTO) defined as coronary lesion with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 on initial angiography present for more than or equal to 3 months. 7. Left main coronary artery disease 8. Patients who cannot give informed consent or have a life expectancy of less than 12 months. 9. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors. 10. Patients with an extreme LAD tortuosity imparing OCT catheter advancement 11. Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint . The patient may only be enrolled once in the PRESENT study. 12. Previous coronary artery bypass grafting (CABG). 13. Patient requiring additional cardiac surgery within 6 months. 14. Women of childbearing potential who do not have a negative pregnancy test result within 7 days before the procedure, women who are known to be pregnant, or who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is defined as the composite of death from any cause, stroke, myocardial infarction, or repeat revascularization (MACCE) at 1-year post index procedure, which was compared with a pre-specified objective performance goal (OPG). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Composite outcome of death from any cause, stroke, myocardial infarction, or repeat revascularization (MACCE) at 30 days, 2 and 5 years post intervention. • All-cause mortality at 30 days, 1, 2 and 5 years • Myocardial Infarction at 30 days, 1, 2 and 5 years • Any revascularization at 30 days, 1, 2 and 5 years • Stroke at 30 days, 1, 2 and 5 years • Major bleeding at 30 days and 12 months • Need for renal replacement therapy at 30 days • Feasibility on on-line complete functional assessment using FFRangio Other study parameters: Secondary imaging endpoint • Minimal lumen diameter (QCA) • Percent diameter stenosis (QCA) • Acute lumen gain post-intervention (QCA) • Maximum stent size/reference vessel diameter ratio (QCA) • Angiographic Dissection >= NHLBI type B (QCA) • Angiography-defined procedural success rate: - Defined as a final lesion angiographic diameter stenosis = NHLBI type C, perforation, prolonged chest pain or ST segment elevation or depression changes (>30 minutes), or procedural death. • OCT device success rate (site reported): - Successful OCT imaging obtained pre and post PCI • Peri-procedural myocardial infarction according to the Society of Cardiovascular Angiography and Intervention definition • Post-PCI stent expansion (OCT): - Defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100 • Untreated reference segment disease (OCT): - Defined as untreated MLA 90°-=180° of lipid arc) • Edge dissections (OCT): - Major (%): >=60 degrees of the circumference of the vessel at site of dissection and/or >=3 mm in length - Minor (%): any visible edge dissection =0.2 mm and not associated with any side branch). - Malapposition will be further classified as: Major: If associated with stent underexpansion (unacceptable stent expansion as defined above) Minor: If not associated with significant underexpansion (optimal or acceptable stent expansion as defined above) | — |
Countries
Belgium, Italy, Netherlands, Spain
Contacts
Public ContactRD Diletti
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed