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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021120
Receipt No. R000023995
Scientific Title Open-label multicenter registry on the Outcomes of peripheral arterial disease treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery
Date of disclosure of the study information 2016/04/01
Last modified on 2019/05/21

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Basic information
Public title Open-label multicenter registry on the Outcomes of peripheral arterial disease treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery
Acronym Open-label multicenter registry on the Outcomes of peripheral arterial disease treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery (OCEAN-SFA study)
Scientific Title Open-label multicenter registry on the Outcomes of peripheral arterial disease treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery
Scientific Title:Acronym Open-label multicenter registry on the Outcomes of peripheral arterial disease treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery (OCEAN-SFA study)
Region
Japan

Condition
Condition peripheral arterial disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will perform balloon angioplasty for treatment of de novo superficial femoral artery lesions, and we evaluate vascular responses at the site of balloon angioplasty by (OFDI). We identify the factors defining restenosis by evaluating the relationships between OFDI findings and presence of restenosis at 6 months after balloon angioplasty in this prospective registry.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes presence of restenosis by ultrasound at 6 months after balloon angioplasty
Key secondary outcomes Rutherford category at 6 months after balloon angioplasty

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Optical Frequency Domain Imaging
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 diagnosed as peripheral arterial disease and scheduled endvascular therapy for de novo superficial femoral artery lesions
2)patients aged over 20 years at the time of informed consent
3)patients who can undestand this study and provide informed consent written
4)ankle brachial index 0.9
5)PAD(Tasc A or B categories)
6)PAD(Rutherford 1-5 categories)
Key exclusion criteria 1)terminal illness in whom life expectancy is expected to be less than 6 months
2)previous stent implantation in the
targeted SFA lesion
3)acute limb ischemia or acute thrombotic occlusion
4)patients with no arterial runoff below the knee
5)patients with uncontrollable heart failure
6)patients can not recieve antiplatelet therapy
7)female patients during pregnancy or breast-feeding
8)patients who are judged inappropriate for this trial by their attending physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirata Ken-ichi
Organization Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-2 Kusunokicho, Chuoku, Kobe-city, Hyogo
TEL 078-382-5111
Email hiratak@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiro Tsukiyama
Organization Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-2 Kusunokicho, Chuoku, Kobe-city, Hyogo
TEL 078-382-5111
Homepage URL
Email yoshiro.tsukiyama0920@gmail.com

Sponsor
Institute Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization DAIICHI SANKYO COMPANY
Organization
Division
Category of Funding Organization Profit organization
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 04 Month 01 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 Completed
Date of protocol fixation
2016 Year 02 Month 10 Day
Date of IRB
2016 Year 03 Month 23 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2018 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 21 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023995

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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