UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054963 |
|---|---|
| Receipt number | R000062802 |
| Scientific Title | Long-term efficacy of drug-coated balloon angioplasty in comparison to drug-eluting stent for de-novo large-vessel coronary artery disease |
| Date of disclosure of the study information | 2024/07/14 |
| Last modified on | 2024/07/14 21:51:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Long-term efficacy of drug-coated balloon angioplasty in comparison to drug-eluting stent for large vessel coronary artery disease
Acronym
Long-term efficacy of drug-coated balloon angioplasty in comparison to drug-eluting stent for large vessel coronary artery disease
Scientific Title
Long-term efficacy of drug-coated balloon angioplasty in comparison to drug-eluting stent for de-novo large-vessel coronary artery disease
Scientific Title:Acronym
Long-term efficacy of drug-coated balloon angioplasty in comparison to drug-eluting stent for de-novo large-vessel coronary artery disease
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) angioplasty is one of the effective managements for treating in-stent restenosis or de-novo small-vessel (vessel diameter <3.0mm) coronary artery disease (CAD), compared with PCI with drug-eluting stent (DES) implantation. However, the safety and effectiveness of DCB angioplasty for large vessel CAD compared to PCI with drug-eluting stents remains unclear.
This study aimed to evaluate the long-term cardiovascular outcomes (up to 5 years) after PCI with DCB angioplasty as compared to PCI with everolimus-eluting stents, de-novo for large-vessel CAD (vessel diameter 3.0mm or above).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of cardiovascular events during 5 years after the index PCI
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study included patients received PCI with either DCB or everolimus-eluting stent (EES) for de-novo large-vessel coronary artery lesions (3.0mm or above) from January 2016 to December 2018.
Key exclusion criteria
The following points were excluded from this study: 1) lesions treated with any stents in the target vessel, and 2) procedures including a mixture of DCB and stent implantation in different sites lesions.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Hyogo Prefectural Harima-Himeji General Medical Centre
Division name
Cardiovascular Medicine
Zip code
670-8560
Address
3-264 Kamiya-cho, Himeji, Japan
TEL
079-289-5080
y0493589m@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Hyogo Prefectural Harima-Himeji General Medical Centre
Division name
Cardiovascular Medicine
Zip code
079-289-5080
Address
3-264 Kamiya-cho, Himeji, Japan
TEL
079-289-5080
Homepage URL
y0493589m@hotmail.co.jp
Sponsor or person
Institute
Hyogo Prefectural Harima-Himeji General Medical Centre
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Prefectural Harima-Himeji General Medical Centre
Address
3-264 Kamiya-cho, Himeji, Japan
Tel
079-289-5080
jhisyo@hgmc.hyogo.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
| 2024 | Year | 07 | Month | 14 | 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
399
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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This single-center retrospective observational study included patients received PCI with either DCB or everolimus-eluting stent (EES) for de-novo large-vessel coronary artery lesions (3.0mm or above) in Harima-Himeji General Medical Center from January 2016 to December 2018. In all patients who were treated with DCB angioplasty, the paclitaxel-coated balloon (PCB, SeQuent Please Neo, B. Braun, Berlin, Germany) was used. In patients underwent DES implantation, patients treated with everolimus-eluting stent (EES, Xience Alpine, Abbott Vascular, Santa Clara, California) were enrolled in the present study.
The following points were excluded from this study: 1) lesions treated with any stents in the target vessel, and 2) procedures including a mixture of DCB and stent implantation in different sites lesions. The decision on how to perform lesion preparation before treating DCB or DES and whether using DCB or DES were made by operators.
Clinical information was carefully reviewed through electronic medical records from our hospital, including baseline patient characteristics, coronary lesion characteristics, procedural details, and procedural results.
Management information
Registered date
| 2024 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062802
