UMIN-CTR Clinical Trial

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
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IRB Contact (For public release)
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Address
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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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