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Prediction of debulking effect of rotational atherectomy by optical frequency domain imaging (OFDI)

Prediction of debulking effect of rotational atherectomy by optical frequency domain imaging (OFDI) - RA-OFDI registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000035634
Enrollment
60
Registered
2019-02-01
Start date
2019-03-18
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 heart disease

Interventions

None listed

Sponsors

Kobe University graduate school of medicine, Department of Cardiology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who scheduled rotational atherectomy for severe coronary artery calcification lesions, those that satisfied the following criteria was registered. 1. Patient who was over 20 years old at the time of PCI. 2. Patient who planed to use rotational atherectomy during PCI. 3. Patients who have severe coronary artery calcification lesions (radiopaque calcified lesions, calcified lesions of more than 180 degrees in OFDI images, or mineralized lesions protruding into the lumen). 4. Patients who can perform intravascular evaluation by OFDI before and after rotational atherectomy. 5. Patients who was able to obtain good analyzable OFDI images. 6. Patients who wrote informed concent by himself/herself.

Exclusion criteria

Exclusion criteria: 1. Patient with acute coronary syndrome. 2. Patient with cardiogenic shock. 3. Patient with in-stent restenosis. 4. Patient with chronic total obstructive lesion. 5. Patient with graft lesion after coronary artery bypass surgery. 6. Patients judged inappropriate by the doctor in charge of this study.

Design outcomes

Primary

MeasureTime frame
Calculation of prediction accuracy (correct and error rate) of Rotational atherectomy based on OFDI images

Secondary

MeasureTime frame
1. Percentage of adverse event occurrence (coronary artery perforation, coronary dissection, peri-procedural myocardial infarction, slow-flow / no-reflow phenomenon, rota burr entrapment) 2. Investigation of factors related to prediction accuracy

Countries

Japan

Contacts

Public ContactKosuke Tanimura

Kobe University graduate school of medicine Department of Cardiology

k.tanimura1006@gmail.com078-382-5846

Outcome results

None listed

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