UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034867 |
|---|---|
| Receipt number | R000038078 |
| Scientific Title | Impact of 1-month Dual Antiplatelet Therapy After Treatment with Drug-Coated Balloon for Femoropopliteal Artery Disease |
| Date of disclosure of the study information | 2018/11/12 |
| Last modified on | 2024/01/18 13:07:39 |
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Basic information
Public title
Impact of 1-month Dual Antiplatelet Therapy After Treatment with Drug-Coated Balloon for Femoropopliteal Artery Disease
Acronym
1-month DAPT After Treatment with DCB for Femoropopliteal Artery Lesions
Scientific Title
Impact of 1-month Dual Antiplatelet Therapy After Treatment with Drug-Coated Balloon for Femoropopliteal Artery Disease
Scientific Title:Acronym
1-month DAPT After Treatment with DCB for Femoropopliteal Artery Lesions
Region
| Japan |
Condition
Condition
Arteriosclerosis obliterans
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of 1-month DAPT after treatment with DCB for femoropopliteal artery disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary petency at 12 months
Key secondary outcomes
The incidence of thrombosis at 12 months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with femoropopliteal artery disease which are suitable to be received DCB therapy
Key exclusion criteria
Patients who are needed to receive long-term DAPT
Patients who are treated with anticoagulant agent
Patients without tolerance to aspirin or clopidogrel
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ishihara |
| Middle name | |
| Last name | Masaharu |
Organization
Hyogo College of Medicine
Division name
Division of Cardiovascular Medicine and Coronary Heart Disease
Zip code
663-8131
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 6638501, Japan
TEL
0798-45-6553
hpxkg043@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Kojiro |
Organization
Hyogo College of Medicine
Division name
Division of Cardiovascular Medicine and Coronary Heart Disease
Zip code
663-1831
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 6638501, Japan
TEL
0798-45-6553
Homepage URL
hpxkg043@ybb.ne.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 6638501, Japan
Tel
0798-45-6553
rinsys@hyo-med.ac.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
兵庫医科大学病院(兵庫県)、東宝塚さとう病院(兵庫県)、川崎病院(兵庫県)、明和病院(兵庫県)、桜橋渡辺病院(大阪府)、多根総合病院(大阪府)、森之宮病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 12 | 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
151
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients are received 1-month DAPT after DCB therapy. After 1-month DAPT, they are received only aspirin up to 1 year.
Management information
Registered date
| 2018 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038078
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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