OptimalCare Study

Not Applicable

Recruiting

• Conditions: Stable angina; Stable angina, Chronic coronary syndromes, Coronary artery disease; D060050

• Registration Number: JPRN-jRCT1040230051
• Lead Sponsor: Kinoshita Yoshihisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

[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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in minimum lumen area (MLA) before and after debulking process [Time Frame: Immediately before using final device]

Secondary Outcome Measures

Name	Time	Method
1. Procedural Success<br>2. Acute gain<br>3. Creatinine Kinase (CK-MB) level<br>4. MACE at 12 months<br>5. Procedural time<br>6. Contrast volume