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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040498
Receipt No. 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 2020/05/23

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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
Email 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
Email isa_tsuyo@yahoo.co.jp

Sponsor
Institute Sendai Kousei Hospital
Institute
Department

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
Email 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 No longer recruiting
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 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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