UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055953 |
|---|---|
| Receipt number | R000063938 |
| Scientific Title | Long-Term Outcomes of True versus Non-True Coronary Bifurcation Lesions Treated with Bioresorbable Polymer Sirolimus-Eluting Ultimaster Stent |
| Date of disclosure of the study information | 2024/10/26 |
| Last modified on | 2025/04/26 20:33:22 |
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Basic information
Public title
Long-Term Outcomes of True versus Non-True Coronary Bifurcation Lesions Treated with Bioresorbable Polymer Sirolimus-Eluting Ultimaster Stent
Acronym
Bifurcation post hoc analysis of the SCVC registry
Scientific Title
Long-Term Outcomes of True versus Non-True Coronary Bifurcation Lesions Treated with Bioresorbable Polymer Sirolimus-Eluting Ultimaster Stent
Scientific Title:Acronym
Bifurcation post hoc analysis of the SCVC registry
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the long-term outcomes of true versus non-true coronary bifurcation lesions treated with bioresorbable polymer sirolimus-eluting stents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target vessel failure (TVF), defined as a composite of cardiac death, target-vessel related myocardial infarction (TVMI), and clinically driven target vessel revascularization (CDTVR).
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
Of 1727 cases enrolled in the SCVC registry, bifurcation lesions treated with bioresorbable polymer sirolimus-eluting Ultimaster stent were included in this study.
Key exclusion criteria
None
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Sapporo Cardiovascular Clinic
Division name
Cardiovascular Medicine
Zip code
007-0849
Address
North 49, East 16, 8-1, Higashi Ward, Sapporo, Japan
TEL
0117847847
kuramitsu@heart-kizuna.com
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Sapporo Cardiovascular Clinic
Division name
Cardiovascular Medicine
Zip code
007-0849
Address
North 49, East 16-1, Higashi Ward, Sapporo, Japan
TEL
0117847847
Homepage URL
kuramitsu@heart-kizuna.com
Sponsor or person
Institute
Sapporo Cardiovascular Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Cardiovascular Clinic
Address
North 49, East 16-1, Higashi Ward, Sapporo, Japan
Tel
0117847847
kuramitsu@heart-kizuna.com
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 | 10 | Month | 26 | 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
440
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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective, observational study at a single center
Management information
Registered date
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063938
