UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002605 |
|---|---|
| Receipt number | R000002736 |
| Scientific Title | Efficacy of Rotational athelectomy in the treatmentof dialysis patients evaluated by IVUS examination trial in Nagano prefecture |
| Date of disclosure of the study information | 2009/10/15 |
| Last modified on | 2009/10/08 17:55:25 |
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Basic information
Public title
Efficacy of Rotational athelectomy in the treatmentof dialysis patients evaluated by IVUS examination trial in Nagano prefecture
Acronym
E-RIDE in Nagano
Scientific Title
Efficacy of Rotational athelectomy in the treatmentof dialysis patients evaluated by IVUS examination trial in Nagano prefecture
Scientific Title:Acronym
E-RIDE in Nagano
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the pre-treatment using the Rotational athelectomy in the implantation of the dlug eluting stent, compare with the pre-treatment using the POBA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of the target vessel failure(TVF) eight month after prodcedure
Key secondary outcomes
frequency of the achievment of the ND80%
ND80%: minimum lumen diameter/stent diameter >80% (ND80%)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group P(treatment with POBA before DES implantation)
Interventions/Control_2
Group R(treatment with Rotablator before DES implantation)
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
1. more than 20 years old
2. patients who suit the indications of PCI
3. patients who agree with this trial with the informed concent sheet
4. patients who can intake the anti-platelets drugs within a year
5. patients whose coronary artery has significant narrowings in the proximal and mid lesion
6. patients whose reference lesion are 2.75-4.00mm
7. patients who suit the indications of DES
Key exclusion criteria
1. patients of AMI(within 7days)
2. patients who enroll another trials
3. patients who have the history of the side effect of aniplatelet drugs
4. patients who have severe liver disfunction
5. patients whose ejection fraction of LV were less than 40%
6. patients of ACS
7. patients of chronic total occlusion of the target vessel
8. patients of the left main coronary artery disease
9. patients of the triple vessel disease
10 patients of the in-sten restenosis
11. patients whose target lesion are vein bypass graft
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Miyashita |
Organization
Shinshu University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
3-1-1 Asahi Matsumoto 390-8621
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinshu University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Shinshu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 08 | Day |
Last modified on
| 2009 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002736
