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OptimalCare Study

Prospective, Multi-center, Single-arm, Observational Study to Evaluate Safety and Efficacy of the OA+RA Combined Technique in Subjects with Eccentric Calcified Lesion

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1040230051
Enrollment
200
Registered
2023-06-25
Start date
2023-06-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable angina Stable angina, Chronic coronary syndromes, Coronary artery disease

Interventions

None listed

Sponsors

Kinoshita Yoshihisa
Lead Sponsor

Eligibility

Sex/Gender
All

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

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

Secondary

MeasureTime 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

Public ContactAkinobu Takemura

Toyohashi Heart Center

takemura@heart-center.or.jp+81-532-37-3377

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026