Coronary artery disease requiring PCI treatment
Conditions
Interventions
Subjects are assigned to either Orsiro Arm or XIENCE Arm prior to PCI.
Sponsors
Nakamura Masato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Symptomatic coronary artery disease 2. Subject is acceptable for angiography and willing to comply with all study followup requirements. 3. Subject is 20 years old or older. 4. Subject who requires PCI medically
Exclusion criteria
Exclusion criteria: 1. Subject is unable to provide written informed consent. 2. Contraindication to antithrombotic therapy and/or anticoagulant therapy. 3. Difficulty in adequate pharmacotherapy. 4. Contraindication and/or allergy to contrast medium. 5. Planned cardiac surgery. 6. Subject is participating in another study and the observation period has not completed. 7. In the investigator's or sub-investigator's opinion, subject is deemed inappropriate for participating to study .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF) post stent replacement | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy] Device success Lesion success (residual stenosis < 30%) Procedure success [Safety] Myocardial infarction Myocardial infarction and cardiac death Major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) Individual TLF components Target vessel failure (TVF) and individual TVF components Stent thrombosis based on ARC definition Bleeding events (Bleeding category based on BARC Classification, Major bleeding and Minor bleeding with reference to TIMI Classification) | — |
Contacts
Public ContactMasato Nakamura
Toho University, Ohashi Medical Center
Outcome results
None listed