UMIN-CTR Clinical Trial

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
Last 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
1st 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