UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055750 |
|---|---|
| Receipt number | R000063709 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2024/10/05 |
| Last modified on | 2024/10/05 15:00:05 |
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Basic information
Public title
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
Acronym
EROSION-ELCA DCB Trial
Scientific Title
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
Scientific Title:Acronym
EROSION-ELCA DCB Trial
Region
| Japan |
Condition
Condition
Study population 1. Acute coronary syndrome presenting with plaque erosion
Study population 2. Acute coronary syndrome presenting with excepting for plaque erosion
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study population 1. A multi-center randomized control study to verify whether percutaneous coronary intervention (PCI) with excimer laser and drug-eluting balloon improves the success rate of PCI without metallic stents compared to PCI with thrombus aspiration in acute coronary syndrome with plaque erosion.
Study population 2. Prospective observational studies for acute coronary syndromes caused by excepting for plaque erosion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Percutaneous coronary intervention using excimer laser and drug-eluting balloon in patients with acute coronary syndromes caused by plaque erosion.
Interventions/Control_2
Percutaneous coronary intervention using thrombus aspiration only for acute coronary syndromes caused by plaque erosion.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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)
Key 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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Tanaka |
Organization
Wakayama Medical University
Division name
Cardiovascular medicine
Zip code
6418509
Address
811-1, Kimiidera Wakayama city Wakayama prefecture
TEL
0734472300
a-tanaka@wakayama-me.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Takahata |
Organization
Wakayama Medecarl University
Division name
Cardiovascular medicine
Zip code
6418509
Address
811-1, Kimiidera Wakayama city Wakayama prefecture
TEL
0744472300
Homepage URL
masahiro.t72@gmail.com
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1, Kimiidera Wakayama city Wakayama prefecture
Tel
0734472300
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063709
