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

JRCT ID: jRCT1052240139

Registered date:30/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Ischemic heart disease (stable angina, unstable angina, non-ST elevated myocardial infarction)
• Date of first enrollment: 30/09/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Rondamization for Ultimaster or COMBO Plus use

Outcome(s)

• Primary Outcome: The difference of neointimal (NIH) thickness evaluated byfollow-up OFDI/OCT images in Ultimaster and Combo Plus

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: > 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fukuda Daiju
• Secondary Sponsor: Yamaguchi Tomohiro