UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019739 |
|---|---|
| Receipt number | R000022796 |
| Scientific Title | A randomized comparison of elective transradial coronary intervention using 6.5-Fr Sheathless Eaucathe guide catheter vs. 6.0-Fr glide sheath |
| Date of disclosure of the study information | 2016/01/10 |
| Last modified on | 2017/11/19 19:03:02 |
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Basic information
Public title
A randomized comparison of elective transradial coronary intervention using 6.5-Fr Sheathless Eaucathe guide catheter vs. 6.0-Fr glide sheath
Acronym
RCT using Sheathless Eaucathe guide catheter and Glide Sheath Slender
Scientific Title
A randomized comparison of elective transradial coronary intervention using 6.5-Fr Sheathless Eaucathe guide catheter vs. 6.0-Fr glide sheath
Scientific Title:Acronym
RCT using Sheathless Eaucathe guide catheter and Glide Sheath Slender
Region
| Japan |
Condition
Condition
Consecutive patients with stable coronary artery disease who were treated by elective transradial percutaneous coronary intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Both 6.5-Fr sheathless guide catheter and 6-Fr glide sheath were developed as less traumatic system for transradial coronary intervention. The aim of this study is to compare the efficacy and safety between both devices.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was access site complications, including radial artery (RA) spasm during the procedure, ultrasound-evaluated RA occlusion at 1 month.
Key secondary outcomes
The secondary endpoints included procedural success and non-access site complications.
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
6.5-Fr sheathless guide catheter is used during elective percutaneous coronary intervention. The eligible participant can in principle be registered in one or two percutaneous coronary interventions.
Interventions/Control_2
Combination of 6.0-Fr glide sheath slender and conventional 6.0-Fr catheter is used during elective percutaneous coronary intervention. The eligible participant can in principle be registered in one or two percutaneous coronary interventions.
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 stable coronary intervention who are planed to undergo elective transradial coronary intervention
Key exclusion criteria
Patient who are planed to undergo transfemoral coronary intervention or emergent coronary intervention
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Inoue |
Organization
Sendai Kousei Hospital
Division name
Cadiovascular Division
Zip code
Address
4-15, Hirose-cho, Sendai, Miyagi, Japan
TEL
+81-22-222-6181
inouena@est.hi-ho.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Horie |
Organization
Sendai Kousei Hospital
Division name
Cardiovascular Division
Zip code
Address
4-15, Hirose-cho, Sendai, Miyagi, Japan
TEL
+81-22-222-6181
Homepage URL
horihori1015@gmail.com
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
Sendai Kousei 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
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
| 2016 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/28846541
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28846541
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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 25 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 10 | Day |
Last modified on
| 2017 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022796
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/05/03 | 6Fr無作為化のデザイン .docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/12/12 | 6Fr無作為化のデザイン .docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/07/02 | 2017 RCT.xlsx |
