UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003754 |
|---|---|
| Receipt number | R000004548 |
| Scientific Title | Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis |
| Date of disclosure of the study information | 2010/06/14 |
| Last modified on | 2010/06/14 22:45:40 |
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Basic information
Public title
Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis
Acronym
Paclitaxel-eluting Balloon for SES Restenosis
Scientific Title
Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis
Scientific Title:Acronym
Paclitaxel-eluting Balloon for SES Restenosis
Region
| Japan |
Condition
Condition
coronary artery 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 of paclitaxel-eluting balloon (PEB) for the treatment of sirolimus-eluting stent (SES) restenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
late lumen loss
Key secondary outcomes
the rate of binary restenosis and major adverse cardiac events (MACE)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Paclitaxel-Eluting PTCA Balloon (SeQuent Please balloon catheter, B. Braun Melsungen AG, Vascular Systems, Berlin, Germany)
Interventions/Control_2
conventional 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
The patients with ISR after SES implantation with clinical evidence of stable angina.
The target lesion had to be the first ISR after SES implantation with the vessel 2.5-3.5mm in diameter.
Key exclusion criteria
The lesions in the left main coronary artery, or the ostial, bifurcated, or totally occluded lesions were not regarded as the target lesions.
Patients with acute coronary syndrome, severe renal insufficiency (glomerular filtration rate: <30 ml/min), prior stent implantation within 6 months, severe concomitant systemic illness, and conditions likely to preclude follow-up angiography were excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 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
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
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
倉敷中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | 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
| 2008 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 14 | Day |
Last modified on
| 2010 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004548
