UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039919 |
|---|---|
| Receipt number | R000045508 |
| Scientific Title | Vascular responses to COMBO stent for acute coronary syndrome by Optical Coherence Tomography Assessment |
| Date of disclosure of the study information | 2020/03/24 |
| Last modified on | 2020/03/24 12:58:14 |
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Basic information
Public title
Vascular responses to COMBO stent for acute coronary syndrome by Optical Coherence Tomography Assessment
Acronym
Vascular responses to COMBO stent for acute coronary syndrome by Optical Coherence Tomography Assessment
Scientific Title
Vascular responses to COMBO stent for acute coronary syndrome by Optical Coherence Tomography Assessment
Scientific Title:Acronym
Vascular responses to COMBO stent for acute coronary syndrome by Optical Coherence Tomography Assessment
Region
| Japan |
Condition
Condition
The patients with acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the early phase vascular responses in patients with acute coronary syndrome (ACS) after COMBO stent implantation at 1 month follow-up by using optical coherence tomography (OCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was that the degree of strut coverage which was evaluated by OCT at 1 month. Percentage of strut coverage was analyzed every 1 mm by OCT.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
All patients underwent percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) by using Combo stent.All patients were evaluated by Optical Coherence Tomography (OCT) immediately after stent implantation and were performed OCT follow-up after 1 month.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The patients with ACS need for PCI.
2) Target lesions are thought native coronary arteries.
3) The patients are possible to take antiplatelet drugs.
4) The patients or legal representative people agree this study and write informed consents after they understand this study protocol.
Key exclusion criteria
1) The patients with low ejection fraction (less than 20%).
2) The patients with recurrent myocardial infarction within 30 days.
3) The patients with fresh bleeding.
4) The patients with cerebral infarction within 6 months.
5) The patients with hemoglobin < 8.0 g/dl.
6) The patients with WBC <3000 or PLT < 100000.
7) The patients with positive HBV or HCV or HIV.
8) The patients with participate other clinical trial.
9, 10) The patients with pregnant women (including possible) or lactating women
11) The patients with renal failure (Cre>2.5 mg/dl)
12) The patients that research director judged inappropriate patients in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Saito |
Organization
ShonanKamakura General Hospital
Division name
Cardiology
Zip code
247-8533
Address
1370-1, Okamoto, Kamakura City
TEL
0467-46-1717
transradial@kamakuraheart.org
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Shishido |
Organization
ShonanKamakura General Hospital
Division name
Cardiology
Zip code
247-8533
Address
1370-1, Okamoto, Kamakura City
TEL
0467-46-1717
Homepage URL
koki10192002@yahoo.co.jp
Sponsor or person
Institute
ShonanKamakura general Hospital, Cardiology
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
The Tokushukai Group Ethics Committee
Address
1-8-7 Kojimachi, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.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
| 2020 | Year | 03 | Month | 24 | 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 | 03 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 24 | Day |
Last modified on
| 2020 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045508
