UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057688 |
|---|---|
| Receipt number | R000064166 |
| Scientific Title | Comparative Outcomes of Drug-Eluting Stents and Drug-Coated Balloons Following Rotablator Atherectomy for Calcified Coronary Lesions |
| Date of disclosure of the study information | 2025/04/23 |
| Last modified on | 2025/04/23 00:18:58 |
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Basic information
Public title
Comparative Outcomes of Drug-Eluting Stents and Drug-Coated Balloons Following Rotablator Atherectomy for Calcified Coronary Lesions
Acronym
Comparative Outcomes of Drug-Eluting Stents and Drug-Coated Balloons Following Rotablator Atherectomy for Calcified Coronary Lesions
Scientific Title
Comparative Outcomes of Drug-Eluting Stents and Drug-Coated Balloons Following Rotablator Atherectomy for Calcified Coronary Lesions
Scientific Title:Acronym
Comparative Outcomes of Drug-Eluting Stents and Drug-Coated Balloons Following Rotablator Atherectomy for Calcified Coronary Lesions
Region
| Japan |
Condition
Condition
angina pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the treatment outcomes of drug-eluting stents and restenosis-inhibiting balloons following rotablator atherectomy for calcified coronary lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the cumulative one-year incidence of major adverse cardiovascular events, defined as a composite of cardiac death, clinically driven TVR or TLR, and target vessel myocardial infarction.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1,Underwent PCI with either drug-coated balloon angioplasty or second-generation drug-eluting stent implantation (stent diameter under 3mm).
2,Received rotational atherectomy before balloon dilatation.
Key exclusion criteria
1,Presence of in-stent restenosis.
2,Acute coronary syndrome.
Target sample size
710
Research contact person
Name of lead principal investigator
| 1st name | Hisanori |
| Middle name | |
| Last name | Yui |
Organization
Sapporo Cardiovascular Clinic
Division name
Department of Cardiovascular Medicine
Zip code
0070849
Address
North 49, East 16, 8-1, Higashi Ward, Sapporo, Japan.
TEL
0117847847
hyui@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisanori |
| Middle name | |
| Last name | Yui |
Organization
Sapporo Cardiovascular Clinic
Division name
Department of Cardiovascular Medicine
Zip code
0070843
Address
North 49, East 16, 8-1, Higashi Ward, Sapporo, Japan.
TEL
08051435751
Homepage URL
hyui@shinshu-u.ac.jp
Sponsor or person
Institute
Sapporo Cardiovascular Clinic
Institute
Department
Personal name
Hisanori Yui
Funding Source
Organization
Sapporo Cardiovascular Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Cardiovascular Clinic
Address
North 49, East 16, 8-1, Higashi Ward, Sapporo, Japan.
Tel
0117847847
hyui@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
| 2025 | Year | 04 | Month | 23 | 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
710
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We checked the patients condition either in person or over the phone.The primary endpoint is the cumulative one-year incidence of major adverse cardiovascular events, defined as a composite of cardiac death, clinically driven TVR or TLR, and target vessel myocardial infarction. Death was regarded as cardiac death unless other non-cardiac causes could be identified. Death of unknown cause was included in cardiac death. TLR was defined as a repeat revascularization inside or within 5-mm proximal or distal to the target lesion. A TLR was considered clinically indicated if the angiographic percentage diameter stenosis of the target lesion was over 50% by qualitative coronary angiographic assessment, in the presence of ischemic signs or symptoms.
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064166
