UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019931 |
|---|---|
| Receipt number | R000023010 |
| Scientific Title | Safety and efficacy of the transradial percutaneous coronary intervention using sheathless guiding catheters for acute coronary syndrome: A radial ultrasound follow-up study |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2019/12/18 21:58:10 |
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Basic information
Public title
Safety and efficacy of the transradial percutaneous coronary intervention using sheathless guiding catheters for acute coronary syndrome: A radial ultrasound follow-up study
Acronym
Safety and efficacy of the sheathless transradial percutaneous coronary intervention for acute coronary syndrome
Scientific Title
Safety and efficacy of the transradial percutaneous coronary intervention using sheathless guiding catheters for acute coronary syndrome: A radial ultrasound follow-up study
Scientific Title:Acronym
Safety and efficacy of the sheathless transradial percutaneous coronary intervention for acute coronary syndrome
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Feasibility of the sheathless transradial percutaneous coronary intervention (PCI) in patients with acute coronary syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Initial success of the procedure
(2) Coronary ostial dissection
(3) Access-site complications at 1- or 2-day follow-up, including radial artery occlusion, arteriovenous fistula, local infection, pseudoaneurysm, radial access site bleeding and critical upper limb ischemia
Key secondary outcomes
(1) Access-site complications at 30-day follow-up
(2) Major adverse cardiac events at 30-, 180-day and 1-year follow-up, including all-cause death, myocardial infarction, stent thrombosis and target lesion revascularization
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who suffered acute coronary syndrome and underwent ad hoc PCI via radial artery
(2) Ad hoc PCI was done using a 6.5-Fr or 7.5-Fr sheathless guiding catheter (Sheathless Eaucath; Asahi Intecc).
(1) and (2)
Key exclusion criteria
(1) The patients who underwent the procedure via femoral artery
(2) The patients who did not proceed to PCI (no coronary artery disease and patients advised for CABG)
(1) or (2)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaname Takizawa, MD |
Organization
Sendai Kousei Hospital
Division name
Department of Cardiology
Zip code
Address
4-15, Hirose-machi, Sendai, 980-0873, Japan.
TEL
81-22-222-6181
kanametaki@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Isawa, MD |
Organization
Sendai Kousei Hospital
Division name
Department of Cardiology
Zip code
Address
4-15, Hirose-machi, Sendai, 980-0873, Japan.
TEL
81-22-222-6181
Homepage URL
isa_tsuyo@yahoo.co.jp
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
仙台厚生病院（宮城県）, Sendai Kousei Hospital (Miyagi prefecture, Japan)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Cardiovasc Interv Ther. 2019 Dec 6. doi: 10.1007/s12928-019-00632-7. [Epub ahead of print]
Number of participants that the trial has enrolled
500
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 12 | Month | 06 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: observational study
Patient selection: Consecutive patients with acute coronary syndrome who visited our hospital and underwent transradial primary PCI from January 2015 were enrolled.
Measurement: major caydiovascular event (All-cause death, myocardial infarction, stent thrombosis and target lesion revascularization), access-site complications, including radial artery occlusion
Management information
Registered date
| 2015 | Year | 11 | Month | 25 | Day |
Last modified on
| 2019 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023010
