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Percutaneous Coronary Intervention using Excimer Laser and Drug Coated Coronary Balloon versus Thromboaspiration for Acute Coronary Syndrome presenting with Plaque Erosion: multi-center, Randomized Controlled Trial : EROSION-ELCA DCB Trial

Percutaneous Coronary Intervention using Excimer Laser and Drug Coated Coronary Balloon versus Thromboaspiration for Acute Coronary Syndrome presenting with Plaque Erosion: multi-center, Randomized Controlled Trial : EROSION-ELCA DCB Trial - EROSION-ELCA DCB Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055750
Enrollment
100
Registered
2024-10-05
Start date
2024-10-10
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

Study population 1. Acute coronary syndrome presenting with plaque erosion Study population 2. Acute coronary syndrome presenting with excepting for plaque erosion

Interventions

Percutaneous coronary intervention using excimer laser and drug-eluting balloon in patients with acute coronary syndromes caused by plaque erosion. Percutaneous coronary intervention using thrombus as

Sponsors

Wakayama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients who are at least 18 years of age at the time of obtaining consent 2.Patients for whom written consent has been obtained by the patient or legal representative 3.Patients with ACS who have new lesions presenting with PE that are eligible for PCI (Interventional study) 4.Patients with ACS due to cases excepting for PE (observational study)

Exclusion criteria

Exclusion criteria: 1.Patients with cariogenic shock 2.Patients for whom randomization is deemed inappropriate by their physician 3.Patients for whom PCI is deemed inappropriate by their physician 4.Patients with a prognosis of less than 1 year 5.Patients who are participating or will in another study and whose physician determines that the endpoints of this study will be affected.

Design outcomes

Primary

MeasureTime frame
Study population 1. Deploying coronary stenting or not at the end of the procedure Study population 2. 1. Composite cardiovascular events at discharge and within 1 year according to responsible lesion (plaque rupture, calcified nodule, other): all-cause mortality [cardiac death, non-cardiac death,unknown cause of death], myocardial infarction [spontaneous myocardial infarction], revascularisation [target vessel revascularisation, non-target vessel revascularisation], stroke, 2. major bleeding at discharge and within 1 year (BARC3 or 5, ISTH major bleeding) and serious bleeding within 1 year (BARC 3 or 5, ISTH major bleeding)

Secondary

MeasureTime frame
Study population1. 1. Composite cardiovascular events at discharge and within 1 year according to responsible lesion (plaque rupture, calcified nodule, other): all-cause mortality [cardiac death, non-cardiac death,unknown cause of death], myocardial infarction [spontaneous myocardial infarction], revascularisation [target vessel revascularisation, non-target vessel revascularisation], stroke, 2. major bleeding at discharge and within 1 year (BARC3 or 5, ISTH major bleeding) and serious bleeding within 1 year (BARC 3 or 5, ISTH major bleeding), 3.Thrombus volume after aspiration and excimer laser

Countries

Japan

Contacts

Public ContactMasahiro Takahata

Wakayama Medecarl University Cardiovascular medicine

masahiro.t72@gmail.com0744472300

Outcome results

None listed

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