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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002605
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Shinshu University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002736

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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