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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026760
Receipt No. R000030723
Scientific Title A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel disease
Date of disclosure of the study information 2017/03/29
Last modified on 2017/03/29

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Basic information
Public title A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel disease
Acronym A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel disease
Scientific Title A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Atsushi Funatsu
Organization Kyoto Katsura hospital
Division name Cardiovascular center
Zip code
Address Yamadahirao-cho, Nishikyo-ku, Kyoto city
TEL 075-382-3185
Email kcvc.funatsu@katsura.com

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Fujita
Organization Kyoto Katsura hospital
Division name Clinical reserch center
Zip code
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)

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
2017 Year 03 Month 29 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 Completed
Date of protocol fixation
2009 Year 07 Month 23 Day
Date of IRB
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

Other
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

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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