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Randomized controlled trial of Percutaneous Coronary Intervention for Calcified Lesions with Diamondback Versus Rotablator guided by Optical Coherence Tomography

Randomized controlled trial of Percutaneous Coronary Intervention for Calcified Lesions with Diamondback Versus Rotablator guided by Optical Coherence Tomography - DIRO trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037284
Enrollment
100
Registered
2019-07-05
Start date
2019-07-05
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

Patients treated with diamondback Patients treated with rotablator

Sponsors

Osaka Rosai Hospital, Cardiology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) All patients should be over 18 years of age. 2) Patients with stable coronary artery disease must have a clinical indication for percutaneous coronary intervention. 3) The target lesion must be a de novo calcified lesion that has calcification more than 180 degree of arc assessed by OCT. 4) Moderate or severe calcification by angiogram, if OCT does not cross the lesion.

Exclusion criteria

Exclusion criteria: 1)Ostial left main artery or ostial right coronary artery lesions. 2)Female patients of childbearing potential. 3)Life expectancy less than 12 months.

Design outcomes

Primary

MeasureTime frame
Tissue modification and stent outcomes assessed by OCT.

Secondary

MeasureTime frame
Procedural complications (coronary artery perforation, slow/no flow, dissections during procedure and peri-procedural myocardial infarction) and procedural time and contrast volume. Major adverse cardiovascular events at 8 months after the procedure

Countries

Japan

Contacts

Public ContactNaotaka Okamoto

Osaka Rosai Hospital Cardiology

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

Outcome results

None listed

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