UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of the transradial percutaneous coronary intervention using sheathless guiding catheters for acute coronary syndrome: A radial ultrasound follow-up study
Acronym	Safety and efficacy of the sheathless transradial percutaneous coronary intervention for acute coronary syndrome
Scientific Title	Safety and efficacy of the transradial percutaneous coronary intervention using sheathless guiding catheters for acute coronary syndrome: A radial ultrasound follow-up study
Scientific Title:Acronym	Safety and efficacy of the sheathless transradial percutaneous coronary intervention for acute coronary syndrome
Region	Japan

Condition
Condition	Acute coronary syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Feasibility of the sheathless transradial percutaneous coronary intervention (PCI) in patients with acute coronary syndrome
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Initial success of the procedure (2) Coronary ostial dissection (3) Access-site complications at 1- or 2-day follow-up, including radial artery occlusion, arteriovenous fistula, local infection, pseudoaneurysm, radial access site bleeding and critical upper limb ischemia
Key secondary outcomes	(1) Access-site complications at 30-day follow-up (2) Major adverse cardiac events at 30-, 180-day and 1-year follow-up, including all-cause death, myocardial infarction, stent thrombosis and target lesion revascularization

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	(1) Patients who suffered acute coronary syndrome and underwent ad hoc PCI via radial artery (2) Ad hoc PCI was done using a 6.5-Fr or 7.5-Fr sheathless guiding catheter (Sheathless Eaucath; Asahi Intecc). (1) and (2)
Key exclusion criteria	(1) The patients who underwent the procedure via femoral artery (2) The patients who did not proceed to PCI (no coronary artery disease and patients advised for CABG) (1) or (2)
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kaname Takizawa, MD
Organization	Sendai Kousei Hospital
Division name	Department of Cardiology
Zip code
Address	4-15, Hirose-machi, Sendai, 980-0873, Japan.
TEL	81-22-222-6181
Email	kanametaki@hotmail.com

Public contact
Name of contact person	1st name Middle name Last name Tsuyoshi Isawa, MD
Organization	Sendai Kousei Hospital
Division name	Department of Cardiology
Zip code
Address	4-15, Hirose-machi, Sendai, 980-0873, Japan.
TEL	81-22-222-6181
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	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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）, Sendai Kousei Hospital (Miyagi prefecture, Japan)

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	Cardiovasc Interv Ther. 2019 Dec 6. doi: 10.1007/s12928-019-00632-7. [Epub ahead of print]
Number of participants that the trial has enrolled	500
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 12 Month 06 Day
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 10 Day
Date of IRB	2015 Year 01 Month 12 Day
Anticipated trial start date	2015 Year 01 Month 12 Day
Last follow-up date	2019 Year 12 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: observational study Patient selection: Consecutive patients with acute coronary syndrome who visited our hospital and underwent transradial primary PCI from January 2015 were enrolled. Measurement: major caydiovascular event (All-cause death, myocardial infarction, stent thrombosis and target lesion revascularization), access-site complications, including radial artery occlusion

Management information
Registered date	2015 Year 11 Month 25 Day
Last modified on	2019 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023010