UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040498 |
|---|---|
| Receipt number | R000046224 |
| Scientific Title | Slender sheath/guiding catheter combination versus sheathless guiding catheter for acute coronary syndrome: A propensity-matched analysis of the two devices |
| Date of disclosure of the study information | 2020/05/24 |
| Last modified on | 2020/08/20 14:41:38 |
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Basic information
Public title
Slender sheath/guiding catheter combination versus sheathless guiding catheter for acute coronary syndrome: A propensity-matched analysis of the two devices
Acronym
Slender transradial PCI for ACS
Scientific Title
Slender sheath/guiding catheter combination versus sheathless guiding catheter for acute coronary syndrome: A propensity-matched analysis of the two devices
Scientific Title:Acronym
Slender transradial PCI for ACS
Region
| Japan |
Condition
Condition
Acute coronary syndrome (ACS), including ST-elevation myocardial infarction and non-ST-elevation ACS
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to investigate the differences between the 7-Fr Glidesheath slender sheath/7-Fr guiding catheter combination and 7.5-Fr sheathless Eaucath guiding system in terms of access-site complications in transradial percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The endpoints were radial artery occlusion at 30 days, severe radial spasm during PCI, access-site major bleeding within 30 days as defined by the Bleeding Academic Research Consortium type 3 or 5 criteria, coronary ostial dissection by the guiding catheters, and procedural success.
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
ACS patients who underwent transradial PCI
Key exclusion criteria
The exclusion criteria were as follows: (i) PCI via femoral or brachial access, (ii) transradial PCI using guiding catheter systems other than 7.5-Fr sheathless Eaucath guiding catheters or 7-Fr Glidesheath slender sheaths/7-Fr Hyperion guiding catheter (Asahi Intecc) combination, (iii) refusal to participate, and (iv) loss of follow-up.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Department of Cardiology
Zip code
980-0873
Address
4-15, Hirose-machi, Sendai, Japan
TEL
022-222-6181
isa_tsuyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Department of Cardiology
Zip code
980-0873
Address
4-15, Hirose-machi, Sendai, Japan
TEL
022-222-6181
Homepage URL
isa_tsuyo@yahoo.co.jp
Sponsor or person
Institute
Sendai Kousei 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
IRB of the Sendai Kousei Hospital
Address
4-15, Hirose-machi, Sendai, Japan
Tel
022-222-6181
heartcenter@st.cat-v.ne.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
仙台厚生病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | 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
1108
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
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a single-center retrospective study that included ACS patients who underwent transradial PCI in which either the 7-Fr Glidesheath slender/7-Fr guiding catheter or 7.5-Fr sheathless guiding catheter was used.
Management information
Registered date
| 2020 | Year | 05 | Month | 23 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046224
