De Novo Calcified Lesions Treated with Optical Coherence Tomography guidance and Intravascular Lithotripsy Registry

De Novo Calcified Lesions Treated with Optical Coherence Tomography guidance and Intravascular Lithotripsy Registry - DIRO IVL

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051624

Enrollment

Registered

2023-07-17

Start date

2023-07-12

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

Coronary artery disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with stable coronary artery disease eligible for perdutaneous coronary intervention Calcified lesions with OCT-based calcium score of 3 or higher

Exclusion criteria

Exclusion criteria: Left main coronary artery ostium or right coronary artery ostium lesions Patients with a possibility of being pregnant Patients with life expectancy of less than 12 months

Design outcomes

Primary

Measure	Time frame
Stent expansion assessed by opticalcoherence tomography	—

Secondary

Measure	Time frame
Optical coherence tomography findings including tissue modification Complications during the procedure such as perforation, slow or no flow, coronary dissection, periprocedural myocardial infarction Procedure time, contrast volume Clinical events at 8 months after the procedure Optical coherence tomograpy findings at 8 months after the procedure	—

Countries

Japan

Contacts

Public ContactNaotaka Okamoto

Osaka Rosai Hospital Division of Cardiology

okamo10nao@osakah.johas.go.jp072-252-3561

Outcome results