UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017960 |
|---|---|
| Receipt number | R000020669 |
| Scientific Title | Impact of drug-coating balloon on in-stent restenosis compared with conventional treatment: a prospective multicenter OCT registry |
| Date of disclosure of the study information | 2015/06/19 |
| Last modified on | 2016/10/01 12:06:25 |
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Basic information
Public title
Impact of drug-coating balloon on in-stent restenosis compared with conventional treatment: a prospective multicenter OCT registry
Acronym
ISR-OCT registry
Scientific Title
Impact of drug-coating balloon on in-stent restenosis compared with conventional treatment: a prospective multicenter OCT registry
Scientific Title:Acronym
ISR-OCT registry
Region
| Japan |
Condition
Condition
in-stent restenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of drug-coating balloon for in-stent restenosis compared with conventional therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in % Area Stenosis and late lumen loss assessed by OCT
Key secondary outcomes
(1)late lumen loss = minimal lumen diameter post PCI - minimal lumen diameter at 6-month follow-up by QCA
(2)OCT assessment of the patern of neointimal proliferlation at in-stent restenosis
(3)MACE(TLR, MI, cardiac death) at 1 year follow-up
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug-coating balloon
Interventions/Control_2
Conventional treatment (POBA or Drug elutiing stent)
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients meeting all of the following conditions will be included:
1)in-stent restenosis (% stenosis >50% assessed by CAG)
2)between 20 and 85 years old
3)written consent for participation in the study
4)tolerance of dual antiplatelet therapy
Key exclusion criteria
Patients meeting one of the following conditions will be excluded:
1) Left main trunk lesion
2) severe heart failure (NYHA/New York Heart Association stage III or severer)severe liver dysfunction
3) malignancies or other diseases with poor prognosis
4) renal dysfunction (>Cre 2.0mg/dL)
5) past medical history of hypersensitivity to investigational drugs
6) pregnant, lactating, and possibly pregnant women and those planning to become pregnant
7) indication of rotablator or ELCA
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Kobe University Graduate School of Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5111
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Kuroda |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN
TEL
078-382-5846
Homepage URL
kuroro19800115@hotmail.com
Sponsor or person
Institute
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 06 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 18 | Day |
Last modified on
| 2016 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020669
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
