UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050640 |
|---|---|
| Receipt number | R000057523 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2023/03/22 |
| Last modified on | 2024/03/25 16:14:04 |
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Basic information
Public title
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
Acronym
EVALUATION 2
Scientific Title
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
Scientific Title:Acronym
EVALUATION 2
Region
| Japan |
Condition
Condition
Chronic coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the early vascular response following drug-coated balloon for treatment of coronary artery disease with optical coherence tomography in patients with chronic coronary syndrome undergoing PCI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in mean lumen area from post-DCB to 1-month follow-up as assessed by OCT
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic coronary syndrome with de novo multivessel disease
Key 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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ueki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
3908621
Address
Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL
0263-37-3486
yasushi522@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kanzaki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
3908621
Address
Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL
0263-37-3486
Homepage URL
kanzaki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine
Address
1-1-3 Asahi, Matsumoto, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2023 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057523
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