UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015702 |
|---|---|
| Receipt number | R000018252 |
| Scientific Title | The association between rotation frequency and slow flow phenomenon in the coronary rotational atherectomy |
| Date of disclosure of the study information | 2014/11/16 |
| Last modified on | 2016/07/26 20:25:49 |
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Basic information
Public title
The association between rotation frequency and slow flow phenomenon in the coronary rotational atherectomy
Acronym
The association between rotation frequency and slow flow phenomenon in the coronary rotational atherectomy
Scientific Title
The association between rotation frequency and slow flow phenomenon in the coronary rotational atherectomy
Scientific Title:Acronym
The association between rotation frequency and slow flow phenomenon in the coronary rotational atherectomy
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to compare the prevalence of slow flow following rotational atherectomy between low rotational frequency (140,000rpm) vs. high rotational frequency (190,000rpm).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
TIMI-flow grade following rotational atherectomy. Slow flow is defined as TIMI-flow grade 0, 1, and 2.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
low rotational frequency (140,000rpm)
Interventions/Control_2
high rotational frequency (190,000rpm)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are considered to need rotational atherectomy for coronary artery disease.
Patients who give written informed consent for participating study.
Key exclusion criteria
Patients who do not give written informed consent for participating study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Sakakura, MD |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Cardiovascular Medicine
Zip code
Address
1-847 Amanuma, Omiya, Saitama City, Japan 330-8503
TEL
+81-48-647-2111
ksakakura@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Sakakura, MD |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Cardiovascular Medicine
Zip code
Address
1-847 Amanuma, Omiya, Saitama City, Japan 330-8503
TEL
+81-48-647-2111
Homepage URL
ksakakura@jichi.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Jichi Medical University
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
自治医科大学附属さいたま医療センター
Saitama Medical Center, Jichi Medical University
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 02 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 02 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 02 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 16 | Day |
Last modified on
| 2016 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018252
