UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021120 |
|---|---|
| Receipt number | 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 08:56:03 |
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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
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
yoshiro.tsukiyama0920@gmail.com
Sponsor or person
Institute
Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023995
