UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of radial artery injury after transradial intervention : A frequency domain-optical coherence tomography and optical frequency domain imaging study.
Title of the study (Brief title)	Assessment of radial artery injury after TRI using FD-OCT/OFDI.
Region	Japan

Condition
Condition	Consecutive patients with ischemic heart disease who underwent elective transradial coronary intervention using FD-OCT/OFDI
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Radial artery is commonly used as vascular route for coronary intervention because of lower incidence of vascular complications and its safety compared with transfemoral coronary intervention. However, little is known regarding the radial artery injury after transradial intervention. The aim of this study is to investigate the radial artery injury after TRI using FD-OCT/OFDI.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary endpoint is to assess the radial artery injury (intimal flap, medial dissection or thrombus) using FD-OCT/OFDI.
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	FD-OCT/OFDI catheter is inserted through the sheath, and placed at the radial artery ostium. The sheath is extracted to a point of 1cm proximal to the puncture point. After continuous infusion of saline through the sheath, automated pull back(40mm/s) imaging is performed to examine the overall radial artery.
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	Patients with ischemic heart disease who are planned to undergo transradial coronary intervention
Key exclusion criteria	We excluded patients with serum creatinine > 2.0mg/dl or abnormal Allen test.
Target sample size	150

Research contact person
Name of lead principal investigator	Takatoshi Wakeyama
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Division of Cardiology
Address	1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL	+81-834-28-4411
Email	wakeyama@hotmail.com

Public contact
Name of contact person	Takatoshi Wakeyama
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Division of Cardiology
Address	1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL	+81-834-28-4411
Homepage URL
Email	wakeyama@hotmail.com

Sponsor
Institute	Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department

Funding Source
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 10 Day
Anticipated trial start date	2014 Year 01 Month 16 Day
Last follow-up date	2017 Year 09 Month 19 Day
Date of closure to data entry	2017 Year 09 Month 19 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 28 Day
Last modified on	2017 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032993