Coronary Artery Disease / Ischemic Heart Disease
Conditions
Interventions
None listed
Sponsors
Masato Nakamura
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient age 18 and older. - Patient provides written informed consent. - Patient is considered eligible for treatment with drug coated balloons.
Exclusion criteria
Exclusion criteria: - Patient is considered ineligible for treatment with drug coated balloons. - Patient is participating in another investigational clinical trial or RCT which prevents the participation of this registry. - Target lesion is a stent restenosis lesion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) rate at 12 months post procedure. TLF is defined as clinically-driven target lesion revascularization (CD-TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical endpoints measured at hospital discharge, 6 months, 12 months and 36 months. - Clinically-driven TLR rate - TLF rate - Target vessel revascularization (TVR) rate - Target vessel failure (TVF) rate - Myocardial Infarction (Q-wave and non-Q-wave) rate - Cardiac death rate - Non-cardiac death rate - All death rate - Thrombosis related to target lesion rate - Periprocedural endpoints: - Technical success rate - Clinical procedural success rate - Hybrid Strategy ratio - Assessment of Imaging modalities (IVUS and/or OCT) | — |
Contacts
Public ContactNakamura Masato
Toho University Faculty of Medicine
Outcome results
None listed