UMIN-CTR Clinical Trial

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

Coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nishiarai Heart Center Hospital

Institute

Department

Personal name

Organization

Nishiarai Heart Center Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

06

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

06

Month

05

Day

Last modified on

2015

Year

10

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016451