UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008681 |
|---|---|
| Receipt number | R000010204 |
| Scientific Title | A Multicenter Randomized Comparison of Paclitaxel-eluting Balloon Catheter with Conventional Balloon Angioplasty in Patients with Bare-metal Stent Restenosis and Drug-eluting Stent Restenosis |
| Date of disclosure of the study information | 2012/08/14 |
| Last modified on | 2012/08/14 11:55:10 |
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Basic information
Public title
A Multicenter Randomized Comparison of Paclitaxel-eluting Balloon Catheter with Conventional Balloon Angioplasty in Patients with Bare-metal Stent Restenosis and Drug-eluting Stent Restenosis
Acronym
Paclitaxel-eluting Balloon for In-stent restenosis.
Scientific Title
A Multicenter Randomized Comparison of Paclitaxel-eluting Balloon Catheter with Conventional Balloon Angioplasty in Patients with Bare-metal Stent Restenosis and Drug-eluting Stent Restenosis
Scientific Title:Acronym
Paclitaxel-eluting Balloon for In-stent restenosis.
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the efficacy and safety of paclitaxel-eluting balloon for the treatment of In-stent restenosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
target vessel failure (TVF) at 6-month follow-up
Key secondary outcomes
lesion success (attainment of less than 50% in-stent residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis), and procedure success (attainment of a final lesion success and no in-hospital major adverse cardiac events). Secondary angiographic endpoints were in-stent binary restenosis rate and late lumen loss. Secondary clinical endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis, myocardial infarction, death, and major adverse cardiac events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
paclitaxel-eluting balloon
Interventions/Control_2
conventional balloon angioplasty
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
Inclusion criteria were ISR in bare-metal stent or drug-eluting stent (sirolimus-eluting, zotarolimus-eluting or everolimus-eluting stent), reference vessel diameter of 2.0–4.0 mm, and lesion length of less than 22 mm.
Key exclusion criteria
The lesion containing proximal or distal tortuosity with more than 90-degree angle; multiple lesions in the target vessel; total coronary artery occlusion; heavily calcified lesion; lesion in bypass graft; or bifurcation lesion with side branch of larger than 2.0 mm in diameter was not regarded as the target lesion. Clinical exclusion criteria were as follows: left ventricular ejection fraction of less than 30%; myocardial infarction within 72 hr before enrollment; intolerance to antiplatelet or anticoagulant drugs, drugs similar to paclitaxel and contrast media; acute or chronic renal dysfunction with serum creatinine level of not less than 1.5 mg/dL; patients with severe concomitant systemic illness whom the treating physician considered it better to exclude; any coronary intervention procedure within previous 28 days; patients with cerebral infarction, transient cerebral ischemic attack or hemorrhagic gastric ulcer within previous 6 months; women who were pregnant or of childbearing potential; patients with implantation of DES within previous 6months; and patients with left main disease (LMT>50% diameter stenosis).
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Mitsudo |
Organization
Kurashiki Central Hospital
Division name
Department of Cardiology
Zip code
Address
1-1-1 Miwa, kurashiki-shi, Okayama 710-8602, Japan
TEL
+81-86-422-0210
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Habara |
Organization
Kurashiki Central Hospital
Division name
Department of Cardiology
Zip code
Address
1-1-1 Miwa, kurashiki-shi, Okayama 710-8602, Japan
TEL
+81-86-422-0210
Homepage URL
sh10461@kchnet.or.jp
Sponsor or person
Institute
Nipro Corporation (Osaka, Japan)
Institute
Department
Personal name
Funding Source
Organization
Nipro Corporation (Osaka, Japan)
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
Kurashiki Central Hospital, Kurashiki, Japan
Kokura Memorial Hospital, Kokura, Japan
Sendai Kousei Hospital, Sendai, Japan
Kyoto-Katsura Hospital, Kyoto, Japan
Sakakibara Heart Institute, Tokyo, Japan
Osaka University Graduate School of Medicine, Osaka, Japan
Tsuchiya General Hospital, Hiroshima, Japan
Shonan Kamakura General Hospital, Kamakura, Japan
Tokai University Hospital, Isehara, Japan
Kyoto University, Kyoto, Japan
Tokyo Heart Center, Tokyo, Japan
Toho University Ohashi Medical Center, Tokyo, Japan
National Cardiovascular Center, Suita, Japan
Teikyo University Hospital, Tokyo, Japan
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 14 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 14 | Day |
Last modified on
| 2012 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010204
