UMIN-CTR Clinical Trial

Basic information
Public title	A randomized comparison of radial artery injury after 6.0-Fr glide sheath and 6.5-Fr sheathless transradial coronary intervention using FD-OCT/OFDI.
Acronym	A randomized comparison of radial artery injury after 6.0-Fr glide sheath and 6.5-Fr sheathless TRI. (CORAL REEF trial)
Scientific Title	A randomized comparison of radial artery injury after 6.0-Fr glide sheath and 6.5-Fr sheathless transradial coronary intervention using FD-OCT/OFDI.
Scientific Title:Acronym	A randomized comparison of radial artery injury after 6.0-Fr glide sheath and 6.5-Fr sheathless TRI. (CORAL REEF trial)
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	Although both 6.0-Fr glide sheath and 6.5-Fr sheathless guide catheter were developed to minimize radial artery injury, little is known difference regarding this injury. The purpose of this study is to compare the radial artery injury between both devices using FD-OCT/OFDI.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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	The secondary endpoints include radial artery spasm, procedure time ,amount of contrast media and ultrasound-evaluated radial artery occlusion at 8-12 months.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
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	FD-OCT/OFDI catheter is inserted through the sheathless guide catheter, and placed at the radial artery ostium. The sheathless guide catheter is extracted to a point of 1cm proximal to the puncture point. After continuous infusion of saline through the sheathless guide catheter, automated pull back(40mm/s) imaging is performed to examine the overall radial artery.
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	Patients with serum creatinine > 2.0mg/dl or abnormal Allen test.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takatoshi Middle name Last name Wakeyama
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Division of Cardiology
Zip code	745-8522
Address	1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL	+81-834-28-4411
Email	wakeyama@hotmail.com

Public contact
Name of contact person	1st name Takatoshi Middle name Last name Wakeyama
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Division of Cardiology
Zip code	745-8522
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)

IRB Contact (For public release)
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Address	1-1, Kodachou, Shunan, Yamaguchi, Japan
Tel	+81-834-28-4411
Email	chiken2@tokuchuhp.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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 19 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
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	Completed
Date of protocol fixation	2017 Year 08 Month 03 Day
Date of IRB	2017 Year 09 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 19 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 07 Day
Last modified on	2021 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033105