UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022130
Receipt number R000025508
Scientific Title Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography
Date of disclosure of the study information 2016/04/28
Last modified on 2017/11/10 14:24:39

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Basic information

Public title

Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography

Acronym

Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography

Scientific Title

Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography

Scientific Title:Acronym

Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography

Region

Japan


Condition

Condition

ischemic heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the Synergy stent coverage at 2 weeks after implantation for ischemic heart disease with optical coherence tomography

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Percentage of covered struts at 2 weeks after Synergy implantation

Key secondary outcomes

1) Percentage of apposed struts at 2 weeks after Synergy implantation
2) Relation between patients background and the percentage of covered or apposed struts
3) The evaluation of mean stent area, lumen area, neointimal area, and relation between patients background and them.
4) Existence of thrombus, heterogeneity of neointima, neovascularization, stent edge dissection, and relation between patients background and them
5) Percentage of covered struts in the overlapping segments


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Evaluation for neointima with optical coherence tomography (OCT) imaging catheter at 2 weeks after Synergy implantation

Interventions/Control_2


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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients who underwent percutaneous coronary intervention (PCI) for ischemic heart disease, and implanted Synergy stent
2) Patients who plan to undergo additional PCI for residual lesion 2 weeks later

Key exclusion criteria

1) Patients with impaired renal function (eGFR <50ml/min/1.73m2)
2) Patients with severe heart failure (LVEF <30% or NYHA class > 3)

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshio Kobayashi

Organization

Chiba University Hospital

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL

043-222-7171

Email

tsuchiya-chiba@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norikiyo Oka

Organization

Chiba University Hospital

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL

043-222-7171

Homepage URL


Email

norikiyo.oka@ma.point.ne.jp


Sponsor or person

Institute

Chiba University Hospital, Department of Cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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

千葉大学医学部附属病院(千葉県)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 28 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

No longer recruiting

Date of protocol fixation

2016 Year 04 Month 20 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 06 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

2016 Year 04 Month 28 Day

Last modified on

2017 Year 11 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025508


Research Plan
Registered date File name
2017/11/10 臨床試験実施計画書 ver7_20161216.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name