UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049605 |
|---|---|
| Receipt number | R000056496 |
| Scientific Title | Impact of culprit plaque morphology on clinical outcome after drug-coated balloon treatment for patients with acute coronary syndromes. |
| Date of disclosure of the study information | 2023/01/16 |
| Last modified on | 2023/08/12 16:54:22 |
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Basic information
Public title
Impact of culprit plaque morphology on clinical outcome after drug-coated balloon treatment for patients with acute coronary syndromes.
Acronym
Impact of culprit plaque morphology on clinical outcome after drug-coated balloon treatment for patients with acute coronary syndromes.
Scientific Title
Impact of culprit plaque morphology on clinical outcome after drug-coated balloon treatment for patients with acute coronary syndromes.
Scientific Title:Acronym
Impact of culprit plaque morphology on clinical outcome after drug-coated balloon treatment for patients with acute coronary syndromes.
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
New generation drug eluting stents (DES) have resulted in a dramatic reduction of the incidence of restenosis. However, implantation of a coronary stent is accompanied by various risks of intravascular complications including stent thrombosis and in-stent restenosis [1, 2]. Recently, drug-coated balloons (DCB) have been reported to be noninferior to stent implantation for small vessel coronary artery disease in chronic coronary syndrome (CCS) [3]. Also, albeit small numbers, several studies have shown the usefulness of the DCB strategy in the setting of acute coronary syndrome (ACS) [4, 5], In addition, recent large-scale registry data has implied a lower risk of DCB strategy for definite thrombosis compared with DES-based strategy [6]. Considering these findings, DCB could be an alternative treatment option to stent implantation for specific lesion subsets not only in patients with CCS but in those with ACS.
The majority of ACS are attributable to 3 underlying mechanisms: plaque rupture (PR); plaque erosion (PE) and calcified nodule (CN) and Optical coherence tomography (OCT) has been demonstrated to accurately classify ACS culprit lesions into one of these etiologies with its high image resolution [7]. Plaque composition, thrombogenicity and inflammation are different among these mechanisms that may drive different outcomes following percutaneous coronary intervention (PCI) especially with DCB [8]. However, there have been no studies systematically assessing the impact of culprit plaque morphology on clinical outcome after DCB treatment for patients with ACS. Therefore, in this study, we aimed to compare clinical outcomes according to the plaque morphology after DCB treatment for ACS patients undergoing OCT evaluation of the culprit plaque.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
target lesion failure: TLF
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients whose culprit lesions were treated with DCB
2. patients with ACS who underwent OCT guided PCI
3. patients over 20 years old.
Key exclusion criteria
(1) patients treated with stent (2) patients with in-stent restenosis or stent thrombosis; (3) patients with shock status; (4) patients with target lesion in a left main coronary artery; (5) patients with coronary artery bypass grafted lesions; (6) patients with missing data; (7) patients with insufficient OCT data quality: and (8) patients with life expectancy < 1 year.
Target sample size
127
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yamamoto |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
Homepage URL
m07100ty@jichi.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
the Ethics Committee of Kobe University Hospital
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-5846
kansatsu@med.kobe-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 | 01 | Month | 16 | 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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 16 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 16 | Day |
Other
Other related information
Retrospective observational trial
Management information
Registered date
| 2022 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056496
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