UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of drug-coating balloon on in-stent restenosis compared with conventional treatment: a prospective multicenter OCT registry
Title of the study (Brief title)	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	Toshiro Shinke
Organization	Kobe University Graduate School of Medicine
Division name	Kobe University Graduate School of Medicine
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	Masaru Kuroda
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 11 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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