Comparison of neointimal coverage of bioabsorbable sirolimus eluting stent and bio-engineered dual therapy stent

Comparison of neointimal coverage of bioabsorbable sirolimus eluting stent and bio-engineered dual therapy stent - COLOMBUS trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1052240139

Enrollment

Registered

2024-09-30

Start date

2024-09-30

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

Ischemic heart disease (stable angina, unstable angina, non-ST elevated myocardial infarction) Ischemic heart disease

Interventions

Rondamization for Ultimaster or COMBO Plus use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who need percutaneous coronary intervention (PCI) for ischemic heart disease (stable angina, unstable angina, non-ST elevated myocardial infarction) 2. atherectomy device (Rotablator or Diamondback 360) use for severe calcified coronary stenosis (calcium angle of more than 180 degree) 3. Compatibility for the use of Ultimaster or COMBO Plus 4. Over 20 years old 5. Written informed consent by the patient

Exclusion criteria

Exclusion criteria: 1. ST elevated myocardial infarction 2. Ostium lesion of right coronary artery, left circumflex artery, and left main trunk 3. distal diameter < 2.5mm 4. chronic total occulusion 5. lesions which need 2 stent strategy 6. Coronary stent before and after the target lesion 7. Patients who are not suitable for stent deployment 8. Allergy of contrast material 9. Chronic kidney disease (eGFR<30mL/min/1.73m2) 10. TIMI0-1 flow at the stent deployment 11. Metal allergy 12. Intorelance for antithrombotic agents 13. Active cancer 14. Contraindication of Ultimaster 15. Contraindication of COMBO Plus 16. Pregnancy 17. Patients who don't have eligibility for the inclusion, which was evaluated by the research directors and co-reseachers

Design outcomes

Primary

Measure	Time frame
The difference of neointimal (NIH) thickness evaluated byfollow-up OFDI/OCT images in Ultimaster and Combo Plus	—

Secondary

Measure	Time frame
A)Covered stent struts per patient B)NIH volume C)NIH area D)NIH obstruction E)Neointima heterogeneity index F)Change of stent lumen area G)Change of stent lumen volume H)Change of lumen area I)Change of lumen volume J)Change of malapposed struts K)Change of distance between vessel wall and malapposed struts L)Length of malapposed area M)Chnage of uncovered struts N)Length of struts without neointima O)Tissue behind the struts P)All cause mortality, fatal and non-fatal myocardial infarction, Unstable angina pectoris requiring hospitalization Q)Revascularization for the stent restenosis R)RVD, MLD, %DS(% diameter stenosis) (QCA) S)Images of OCT Polarimetry T)Normalized standard deviation U)Attenuation coefficient	—

Measure

Time frame

A)Covered stent struts per patient B)NIH volume C)NIH area D)NIH obstruction E)Neointima heterogeneity index F)Change of stent lumen area G)Change of stent lumen volume H)Change of lumen area I)Change of lumen volume J)Change of malapposed struts K)Change of distance between vessel wall and malapposed struts L)Length of malapposed area M)Chnage of uncovered struts N)Length of struts without neointima O)Tissue behind the struts P)All cause mortality, fatal and non-fatal myocardial infarction, Unstable angina pectoris requiring hospitalization Q)Revascularization for the stent restenosis R)RVD, MLD, %DS(% diameter stenosis) (QCA) S)Images of OCT Polarimetry T)Normalized standard deviation U)Attenuation coefficient

—

Contacts

Public ContactTomohiro Yamaguchi

Osaka Metropolitan University Hospital

tomohiro.y.1987@omu.ac.jp+81-6-6645-3801

Outcome results

None listed

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