UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026760 |
|---|---|
| Receipt number | 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 16:32:58 |
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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
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
noriko.fujita@katsura.com
Sponsor or person
Institute
Nipro Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030723
| 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 |
