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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034867
Receipt No. 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 2018/11/12

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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
Middle name
Last name Masaharu Ishihara
Organization Hyogo College of Medicine
Division name Division of Cardiovascular Medicine and Coronary Heart Disease
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 6638501, Japan
TEL 0798-45-6553
Email hpxkg043@ybb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kojiro Miki
Organization Hyogo College of Medicine
Division name Division of Cardiovascular Medicine and Coronary Heart Disease
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 6638501, Japan
TEL 0798-45-6553
Homepage URL
Email hpxkg043@ybb.ne.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
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 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
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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 02 Day
Last follow-up date
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
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038078

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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