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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029037
Receipt No. R000033105
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.
Date of disclosure of the study information 2017/09/19
Last modified on 2018/01/06

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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
Middle name
Last name Takatoshi Wakeyama
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Division of Cardiology
Zip code
Address 1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL +81-834-28-4411
Email wakeyama@hotmail.com

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

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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 07 Day
Last modified on
2018 Year 01 Month 06 Day


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

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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