Stable angina Stable angina, Chronic coronary syndromes, Coronary artery disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: [Patient Background] 1. 18 years of age or older 2. Patients with stable angina 3. Patients with an indication for PCI [Lesion Background] 1. De novo target lesion 2. Target vessel diameter of 2.25 to 4.0 mm 3. Visual stenosis >75 % 4. Calcium Angle between 90 and 360 degrees assessed by angiography or IVUS
Exclusion criteria
Exclusion criteria: [Patient Background] 1. Inability to provide written informed consent 2. Patients with history of myocardial infarction within the previous 1 week 3. Inability to complete 12 months follow-up 4. Inability to take antiplatelet medications 5. Inability to take OA+RA combined technique 6. Patients judged as inappropriate for this study by investigators [Lesion Background] 1. Target lesion located in bypass graft 2. In-stent restenosis as target lesion 3. Chronic total occlusion (CTO) as target lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in minimum lumen area (MLA) before and after debulking process [Time Frame: Immediately before using final device] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Procedural Success 2. Acute gain 3. Creatinine Kinase (CK-MB) level 4. MACE at 12 months 5. Procedural time 6. Contrast volume | — |
Contacts
Toyohashi Heart Center