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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017960
Receipt No. 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

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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
Email 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
Email kuroro19800115@hotmail.com

Sponsor
Institute Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020669

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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