Ischemic heart disease
Conditions
Interventions
None listed
Sponsors
Department of Cardiology, Osaka Police Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any indication for PCI in patients presenting as stable angina, silent ischemia, ACS (STEMI and non-STEMI), with de novo target lesions, deemed at high risk for bleeding and candidates for 1 month DAPT, satisfying at least one on the following criteria: 1. Adjunctive oral anticoagulation treatment planned to continue after PCI 2. Age equal to or more than 75 years old 3. Baseline Hemoglobin less than 11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) 4. Any prior intra-cerebral bleed 5. Any stroke in the last 12 months 6. Hospital admission for bleeding during the prior 12 months 7. Non skin cancer diagnosed or treated less than 3 years 8. Planned daily NSAID (other than aspirin) or steroids for more than 30 days after PCI 9. Planned surgery that would require interruption of DAPT (within next 12 months) 10. Renal failure defined as calculated creatinine clearance less than 40 ml/min 11. Thrombocytopenia (PLT less than 100,000/mm3) 12. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice 13. Expected non-compliance to prolonged DAPT for other medical reasons
Exclusion criteria
Exclusion criteria: 1. Pregnant and breastfeeding women 2. Patients expected not to comply with 1 month DAPT 3. Patients requiring a planned staged PCI procedure more than two weeks after the index procedure 4. Procedure planned to require non-study stents, or stand-alone POBA or stand-alone atherectomy 5. Active bleeding at the time of inclusion 6. Reference vessel diameter less than 2.25 or more than 4.0mm 7. Cardiogenic shock 8. Compliance with long-term single anti-platelet therapy unlikely 9. Known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, umirolimus (also known as biolimus A9) or a sensitivity to contrast media, which cannot be adequately pre-medicated 10. PCI during the previous 6 months for a stable lesion other than the target lesion of the index procedure OR PCI during the previous 12 months for a ACS lesion other than the target lesion of the index procedure 11. Participation in another clinical trial (up to 12 months after index procedure) 12. Patients with a life expectancy of less than 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing Score at 3 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT Endpoints (3 months) 1. All individual components of the Healing Score at 3 months; 2. Mean/minimal scaffold/stent diameter/area/volume at 3 months; 3. Mean/minimal lumen diameter/area/volume at 3 months; 4. Incomplete strut apposition (ISA) area/volume at 3 months; 5. Percentage of covered struts at 3 months; 6. Mean/maximal thickness of the struts coverage at 3 months; 7. Neointimal hyperplasia area/volume at 3 months; 8. Mean Flow area/volume at 3 months; 9. Intraluminal defect area/ volume at 3 months; 10. Thickness of neointimal tissue at 3 months. Angioscopy Endpoint (3months) Maximum and minimum neointima coverage grade, maximum yellow color grade, and presence or absence of thrombus was determined for each stented lesion. Clinical endpoints: (at discharge, 3 months and 12 months) 1. Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target vessel revascularization, and its individual components 2. Death All-cause death Cardiac death Non-cardiac death 3. Myocardial infarction according to the Third universal definition Q wave Myocardial Infarction Non-Q wave Myocardial Infarction All Myocardial Infarction 4. Stent Thrombosis per ARC definition7 Definite, Probable and Possible 5. Target lesion revascularization All TLR Clinically driven TLR Not clinically driven TLR 6. Target vessel revascularization All TVR Clinically driven TVR Not clinically driven TVR 7. Non-target vessel revascularization All NTVR Clinically driven NTVR Not clinically driven NTVR 8. All coronary revascularization | — |
Countries
Japan
Contacts
Public ContactSotomi Yohei
Osaka Police Hospital Cardiology
Outcome results
None listed