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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014176
Receipt No. R000016451
Scientific Title The Effects of Predilation with Scoring Balloon Compared to Conventional Balloon on Everolimus-eluting Stent Expansion Analyzed with Optical Coherent Tomography
Date of disclosure of the study information 2014/06/06
Last modified on 2015/10/10

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Basic information
Public title The Effects of Predilation with Scoring Balloon Compared to Conventional Balloon on Everolimus-eluting Stent Expansion Analyzed with Optical Coherent Tomography
Acronym Scoring Compared to Conventional Ballooning on Everolimus-eluting Stent Expansion
Scientific Title The Effects of Predilation with Scoring Balloon Compared to Conventional Balloon on Everolimus-eluting Stent Expansion Analyzed with Optical Coherent Tomography
Scientific Title:Acronym Scoring Compared to Conventional Ballooning on Everolimus-eluting Stent Expansion
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Stent expansion remains one of important predictors of restenosis and subacute thrombosis, even in use of the drug-eluting stent. In those patients, the role of different predilation strategies has yet to be established. Moreover, in the bioresorbable vascular scaffold era, sufficient lesion preparation is essential for their appropriate apposition. The aim of this study was to clarify the impact of lesion preparation using the scoring balloon on final stent expansion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of achieved to predicted stent area after deployment measured by optical coherent tomography (OCT)
Key secondary outcomes i) Binary stent restenosis at remote phase (QCA)
ii) Target vessel diameter/area after balloon angioplasty (OCT)
iii) All-cause mortality, MACE (Major Adverse Cardiac Event)

Base
Study type Interventional

Study design
Basic design Parallel
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 Non-calcified coronary artery atherosclerotic lesions (calcification <50% of circumference) predilated with semi-compliant conventional balloon followed by a single 2.5-3.0 mm Cobalt-chromium Everolimus-eluting stent deployment under optical coherent tomography (OCT) guidance without post-stenting dilation.
Interventions/Control_2 Non-calcified coronary artery atherosclerotic lesions (calcification <50% of circumference) predilated with semi-compliant Scoring balloon followed by a single 2.5-3.0 mm Cobalt-chromium Everolimus-eluting stent deployment under optical coherent tomography (OCT) guidance without post-stenting dilation.
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 Consecutive patients undergoing staged PCI in a single cardiovascular center.
(i) Referential vessel diameter estimated by OCT ((prox.+dist.)/2): 2.5-3.0 mm
(ii) Lesion that is able to be covered by a single stent
(iii) Lesion with calcification less than 50% of circumference
Key exclusion criteria (i) Acute coronary syndrome
(ii) Pregnant patients
(iii) Patients with malignant neoplasm whose life expectancies of less than 6 months
(iv) Patients underwent prior PCI/CABG within 6 months
(v) Patients with decompensated heart failure
(vi) Patients with chronic kidney disease > stage 4
(vii) Patients with allergic reaction against ASA or clopidogrel
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Jujo
Organization Nishiarai Heart Center Hospital
Division name Department of Cardiology
Zip code
Address 1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL +81358380730
Email juken1123@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Jujo
Organization Nishiarai Heart Center Hospital
Division name Department of Cardiology
Zip code
Address 1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL +81358380730
Homepage URL
Email juken1123@hotmail.co.jp

Sponsor
Institute Nishiarai Heart Center Hospital
Institute
Department

Funding Source
Organization Nishiarai Heart Center Hospital
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
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
2014 Year 06 Month 06 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
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 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
2014 Year 06 Month 05 Day
Last modified on
2015 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016451

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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