Prospective observational study to evaluate using OCT in stent neoatherosclerosis for patients after Everolimus-eluting stent (EES) implantation in the late phase.

Prospective observational study to evaluate using OCT in stent neoatherosclerosis for patients after Everolimus-eluting stent (EES) implantation in the late phase. - NA-EES registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033927

Enrollment

200

Registered

2018-11-01

Start date

2018-11-07

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: 1)Patients aged 20 years or older at the time of PCI 2)Patients who underwent PCI with acute coronary syndrome (STEMI, NSTEMI, uAP) or sAP and had Everolimus eluting stent implantation. 3)Patients who can obtain analyzable images at the time of OCT and who undergo OCT evaluation 9 months after PCI 4)Patients who were over 3 years after PCI 5)Patients who written consent

Exclusion criteria

Exclusion criteria: 1)Patients who can not written consent 2)Patient judged inappropriate by the attending physician

Design outcomes

Primary

Measure	Time frame
It is aim to evaluate the presence of neoatherosclerosis using OCT in late phase of Everolimus eluting stent implantation, and to examine related factors.	—

Secondary

Measure	Time frame
1)Various data obtained by OCT (Minimum lumen area, Minimum stent area, Average neointimal thickness, Lipid arc, Lipid length, Lipid index, Neoatherosclerosis, Thin cap fibroatheroma(TCFA), Macrophage grade, Peri-strut low intensity areas(PLIA), Neointimal rapture, Thrombi, Neointimal calcification 2)laboratory data (Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, small LDL-C, ApoA-1, ApoB, ApoB/ApoA-1 ratio, Lp(a), TNF-a, IL-6, MMP-9, Fasting plasma glucose, HbA1c 3)Safety endpoint; Major cardiovascular events (MACE), All cause death, Non-cardiac death	—

Measure

Time frame

1)Various data obtained by OCT (Minimum lumen area, Minimum stent area, Average neointimal thickness, Lipid arc, Lipid length, Lipid index, Neoatherosclerosis, Thin cap fibroatheroma(TCFA), Macrophage grade, Peri-strut low intensity areas(PLIA), Neointimal rapture, Thrombi, Neointimal calcification 2)laboratory data (Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, small LDL-C, ApoA-1, ApoB, ApoB/ApoA-1 ratio, Lp(a), TNF-a, IL-6, MMP-9, Fasting plasma glucose, HbA1c 3)Safety endpoint; Major cardiovascular events (MACE), All cause death, Non-cardiac death

—

Countries

Japan

Contacts

Public ContactKosuke Tanimura

Kobe University Graduate School of Medicine Division of Cardiovascular Medicine

k.tanimura1006@gmail.com078-382-5846

Outcome results