Evaluation of Early Vascular Response following Drug-coated Balloon for Treatment of Coronary Artery Disease as Assessed by Optical Coherence Tomography: the EVALUATION 2 study

Evaluation of Early Vascular Response following Drug-coated Balloon for Treatment of Coronary Artery Disease as Assessed by Optical Coherence Tomography: the EVALUATION 2 study - EVALUATION 2

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050640

Enrollment

Registered

2023-03-22

Start date

2023-03-23

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

Chronic coronary syndrome

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic coronary syndrome with de novo multivessel disease

Exclusion criteria

Exclusion criteria: 1. Coronary stents in the target lesion. 2. Acute coronary syndrome. 3. Acute decompensated heart failure. 4. Non-dialysis patients with chronic kidney disease (CKD Stage 4-5: eGFR <30 ml/min/1.73m2). 5. Severe coronary artery calcification undergoing PCI using debulking device. 6. Ostial lesions of left main or right coronary arteries. 7. Contraindication or known allergy against anti-platelet agents or contrast media. 8. Female of childbearing potential or breastfeeding. 9. Patients who are considered inappropriate for the study by the operator.

Design outcomes

Primary

Measure	Time frame
Difference in mean lumen area from post-DCB to 1-month follow-up as assessed by OCT	—

Secondary

Measure	Time frame
Difference in the following variables from post-DCB to 1-month follow-up as assessed by OCT Minimal lumen area Eccentricity index Number of dissection per lesion Mean dissection length Mean dissection angle Maximum dissection angle Number of calcium fracture per lesion Mean calcium fracture length Maximum calcium fracture depth Difference in the following variables from post-DCB to 1-month follow-up as assessed by QCA Minimal lumen diameter %diameter stenosis Difference in the following variables from post-DCB to 1-year follow-up as assessed by OCT Mean lumen area Minimal lumen area Number of dissection per lesion Mean dissection length Mean dissection angle Maximum dissection angle Number of calcium fracture per lesion Mean calcium fracture length Maximum calcium fracture depth Difference in the following variables from post-DCB to 1-year follow-up as assessed by QCA Minimal lumen diameter %diameter stenosis Clinical outcomes at 1-year All-cause death Cardiac death Non-cardiac death Myocardial infarction Target-vessel related myocardial infarction Target-lesion related myocardial infarction Any revascularization Target vessel revascularization Target lesion revascularization In-stent restenosis Stroke Cox regression analysis for restenosis Sub-group analysis Elderly Gender Hemodialysis Diabetes Small vessel Plaque type Plaque angle Dissection angle at post-DCB % diameter stenosis at post-DCB	—

Measure

Time frame

Difference in the following variables from post-DCB to 1-month follow-up as assessed by OCT Minimal lumen area Eccentricity index Number of dissection per lesion Mean dissection length Mean dissection angle Maximum dissection angle Number of calcium fracture per lesion Mean calcium fracture length Maximum calcium fracture depth Difference in the following variables from post-DCB to 1-month follow-up as assessed by QCA Minimal lumen diameter %diameter stenosis Difference in the following variables from post-DCB to 1-year follow-up as assessed by OCT Mean lumen area Minimal lumen area Number of dissection per lesion Mean dissection length Mean dissection angle Maximum dissection angle Number of calcium fracture per lesion Mean calcium fracture length Maximum calcium fracture depth Difference in the following variables from post-DCB to 1-year follow-up as assessed by QCA Minimal lumen diameter %diameter stenosis Clinical outcomes at 1-year All-cause death Cardiac death Non-cardiac death Myocardial infarction Target-vessel related myocardial infarction Target-lesion related myocardial infarction Any revascularization Target vessel revascularization Target lesion revascularization In-stent restenosis Stroke Cox regression analysis for restenosis Sub-group analysis Elderly Gender Hemodialysis Diabetes Small vessel Plaque type Plaque angle Dissection angle at post-DCB % diameter stenosis at post-DCB

—

Countries

Japan

Contacts

Public ContactYusuke Kanzaki

Shinshu University School of Medicine Department of Cardiovascular Medicine

kanzaki@shinshu-u.ac.jp0263-37-3486

Outcome results