UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel disease
Title of the study (Brief title)	A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel disease
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the safety and efficacy of paclitaxel-coated balloon with plain balloon for coronary artery small vessel disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Target vessel failure
Key secondary outcomes	Procedural success Clinical success MACE TLR Restenosis Late lumen loss

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Paclitaxel-coated balloon
Interventions/Control_2	Plain balloon
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	Stable or unstable angina or asymptomatic myocardial ischemia Patients who met the treatment criteria for PCI RVD 2.0mm or larger and <2.75 mm with lesions length <22mm Stenosis of the native coronary artery >50% and <100%
Key exclusion criteria	Acute myocardial infarction within 72 hour after onset; acute cardiac failure; pregnancy or lactation; renal dysfunction (serum creatinine >1.5 mg/dl); low left ventricular function (left ventricular ejection fraction <30%) Contraindications or known intolerance to antiplatelet agents, paclitaxel, or contrast agents Lesions in the left main branch; patients meeting the criteria for coronary artery bypass graft (CABG); lesions 2mm or shorter from a bifurcation; multiple lesions in a single branch; patients with highly calcified lesions that were difficult to dilate with a balloon; high-grade bend lesions 90% or more; Previously undergone placement of a paclitaxel-eluting stent or had undergone DES placement within the preceding 24 weeks
Target sample size	135

Research contact person
Name of lead principal investigator	Atsushi Funatsu
Organization	Kyoto Katsura hospital
Division name	Cardiovascular center
Address	Yamadahirao-cho, Nishikyo-ku, Kyoto city
TEL	075-382-3185
Email	kcvc.funatsu@katsura.com

Public contact
Name of contact person	Noriko Fujita
Organization	Kyoto Katsura hospital
Division name	Clinical reserch center
Address	Yamadahirao-cho, Nishikyo-ku, Kyoto city
TEL	075-391-5811
Homepage URL
Email	noriko.fujita@katsura.com

Sponsor
Institute	Nipro Corporation
Institute
Department

Funding Source
Organization	Nipro Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	2017 Year 03 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 07 Month 23 Day
Anticipated trial start date	2009 Year 10 Month 01 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	2017 Year 03 Month 29 Day
Last modified on	2017 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030723