UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048490 |
|---|---|
| Receipt number | R000055258 |
| Scientific Title | Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/07/27 18:24:19 |
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Basic information
Public title
Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study
Acronym
Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study
Scientific Title
Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study
Scientific Title:Acronym
Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the risk factor for stent failure after drug-eluting stent implantation for calcified nodule.
Basic objectives2
Others
Basic objectives -Others
investigation of risk factor
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target lesion revascularization
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 who underwent OCT-guided PCI from August 2013 to October 2020
(2)patients whose culprit lesion had CN detected by pre PCI OCT
Key exclusion criteria
(1)patients who were not implanted drug-eluting stents (DES) (those treated with drug-coated balloon [DCB], and those treated with percutaneous old balloon angioplasty [POBA] or rotation atherectomy [RA] alone)
(2)those with in-stent restenosis
(3)those with coronary artery bypass grafted lesions
(4)those with insufficient OCT data quality
(5)those who died within a year after the index PCI
Target sample size
120
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
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyo |
| Middle name | |
| Last name | Hamana |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825846
Homepage URL
tomohamachi@yahoo.co.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
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
Kobe university hospital clinical and translational research center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
0783826669
ccrspprt@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
| 2022 | Year | 08 | Month | 01 | 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
120
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
| 2022 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, retrospective, observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 27 | Day |
Last modified on
| 2022 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055258
