UMIN-CTR Clinical Trial

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