UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029037 |
|---|---|
| Receipt number | 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 | 2021/12/22 18:05:41 |
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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 | 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
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
wakeyama@hotmail.com
Sponsor or person
Institute
Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033105
