UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047934 |
|---|---|
| Receipt number | R000054628 |
| Scientific Title | Safety and Efficacy of a Single 48 mm Everolimus-Eluting Stent in Percutaneous Coronary Intervention for Diffuse Coronary Lesions: A propensity score analysis |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2022/06/02 20:36:06 |
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Basic information
Public title
Safety and Efficacy of a Single 48 mm Everolimus-Eluting Stent in Percutaneous Coronary Intervention for Diffuse Coronary Lesions: A propensity score analysis
Acronym
Safety and Efficacy of a Single 48 mm Everolimus-Eluting Stent in Percutaneous Coronary Intervention for Diffuse Coronary Lesions: A propensity score analysis
Scientific Title
Safety and Efficacy of a Single 48 mm Everolimus-Eluting Stent in Percutaneous Coronary Intervention for Diffuse Coronary Lesions: A propensity score analysis
Scientific Title:Acronym
Safety and Efficacy of a Single 48 mm Everolimus-Eluting Stent in Percutaneous Coronary Intervention for Diffuse Coronary Lesions: A propensity score analysis
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare PCI results of a single 48 mm everolimus-eluting stent with two or more DES at our hospital in the same period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse events after 2 years (cardiac death, non-fatal myocardial infarction, target lesion revascularization and in-stent restenosis)
Key secondary outcomes
contrast volume,
duration of procedure
radiation dose
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
Between June 2018 and September 2020, consecutive patients underwent PCI with a single 48mm everolimus-eluting stent or overlapping stents
Key exclusion criteria
Multiple stents without overlap
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sunohara |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
3900802
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263-37-3486
sunoharadaisuke@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sunohara |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
3900802
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263-37-3486
Homepage URL
sunoharadaisuke@shinshu-u.ac.jp
Sponsor or person
Institute
Nagano Municipal Hospita
Institute
Department
Personal name
Funding Source
Organization
No
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 Institutional Clinical Research Review Boards of Nagano Municipal Hospital
Address
1333-1, Tomitake, Nagano, Nagano
Tel
0262951199
sunoharadaisuke@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
| 2022 | Year | 06 | Month | 03 | 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
130
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
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2022 | Year | 06 | Month | 02 | Day |
Last modified on
| 2022 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054628
