UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042271 |
|---|---|
| Receipt number | R000048256 |
| Scientific Title | Early vascular healing of ultra-thin strut polymer-free sirolimus eluting stent in acute coronary syndrome: optical coherence tomography study |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/10/28 16:39:20 |
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Basic information
Public title
Early vascular healing of ultra-thin strut polymer-free sirolimus eluting stent in acute coronary syndrome: optical coherence tomography study
Acronym
USUI-ACS STUDY
Scientific Title
Early vascular healing of ultra-thin strut polymer-free sirolimus eluting stent in acute coronary syndrome: optical coherence tomography study
Scientific Title:Acronym
USUI-ACS STUDY
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate early vascular healing of ultra-thin strut polymer-free sirolimus eluting stent for the treatment of acute coronary syndrome using optical coherence tomography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of covered struts at 3-month
Key secondary outcomes
The percentage of malapposed struts, mean neointimal hyperplasia (NIH) thickness, NIH area, thrombus and dissection
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
Patients who undergo OCT guided PCI for the treatment of acute coronary syndrome and ultra-thin strut polymer-free sirolimus eluting stent is implanted
Patients who are able to undergo OCT examinations of the site of stent placement at 3 months
Patients who are 20 years old and over at the time of informed consent
Patients who have provided informed consent written by themselves
Key exclusion criteria
Female patient during pregnancy
The culprit lesion is the left main coronary trunk or coronary bypass graft
patients who are stable coronary artery diseases
The culprit lesion is the in-stent restenosis
chronic kidney disease as indicated by serum creatinine > 2.0 mg/dl
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | masami |
| Middle name | |
| Last name | nishino |
Organization
osaka rosai hospital
Division name
cardiology
Zip code
591-8025
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3561
mnishino@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | yutaka |
| Middle name | |
| Last name | matsuhiro |
Organization
osaka rosai hospital
Division name
cardiology
Zip code
591-8025
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3561
Homepage URL
junnai-hisho@osakah.johas.go.jp
Sponsor or person
Institute
osaka rosai hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
osaka rosai hospital
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
Tel
072-252-3561
junnai-hisho@osakah.johas.go.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
| 2020 | Year | 11 | 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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We enroll the patients who undergo OCT guided PCI for the treatment of acute coronary syndrome and ultra-thin strut polymer-free sirolimus eluting stent is implanted. 3-month follow up OCT is performed and vascular healing including percentage of covered struts, malapposed struts and NIH thickness is evaluated and compared with those at post procedure.
Management information
Registered date
| 2020 | Year | 10 | Month | 28 | Day |
Last modified on
| 2020 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048256
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
