UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021121 |
|---|---|
| Receipt number | R000023996 |
| Scientific Title | Open-label multicenter registry on the Outcomes of in-stent restenosis 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 08:57:19 |
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Basic information
Public title
Open-label multicenter registry on the Outcomes of in-stent restenosis treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery
Acronym
Open-label multicenter registry on the Outcomes of in-stent restenosis treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery (ISLAND-SFA study)
Scientific Title
Open-label multicenter registry on the Outcomes of in-stent restenosis treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery
Scientific Title:Acronym
Open-label multicenter registry on the Outcomes of in-stent restenosis treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery (ISLAND-SFA study)
Region
| Japan |
Condition
Condition
peripheral arterial disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate restenosis rate at 6 months after balloon angioplasty for patients with in-stent restenosis in superficial femoral artery.And it is to assess lesion by using OFDI before and after balloon angioplasty treatment,
and to evaluate relationship between the OFDI findings and recurrence in-stent restenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Restenosis with duplex ultrasonography at 6 months after balloon angioplasty
Key secondary outcomes
1)Rutherford category at 12 months after balloon angioplasty
2)Restenosis with duplex ultrasonography at 12 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 with in-stent restenosis in superficial femoral artery.
2) peripheral arterial disease (Rutherford 1-5 categories)
3) patients meeting endovascular therapy criteria.
4) patients who can understand this study and provided written informed consent
5) patients aged over 20 years at the time of informed consent
Key exclusion criteria
1)patients with in-stent occlusion in superficial femoral artery.
2)patients with all three occlusion artery below the knee
3)patients with uncontrollable heart failure
4)patients with acute limb ischemia or acute thrombotic occlusion
5)patients can not recieve antiplatelet therapy
6)female patients during pregnancy or breast-feeding
7)patients judged inappropriate for this study by physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Shinke |
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
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Yanaka |
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
yanadoushies@yahoo.co.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, 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
Terminated
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=R000023996
