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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019739
Receipt No. 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

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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
Email 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
Email horihori1015@gmail.com

Sponsor
Institute Sendai Kousei Hospital
Institute
Department

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
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
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
URL(English) https://upload.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


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