UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008166
Receipt number R000009617
Scientific Title NOboRi biolimus A9-Eluting stent for right Coronary OstIum Lesion (NO RECOIL) registry
Date of disclosure of the study information 2012/06/20
Last modified on 2012/06/14 07:29:38

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Basic information

Public title

NOboRi biolimus A9-Eluting stent for right Coronary OstIum Lesion (NO RECOIL) registry

Acronym

NO RECOIL registry

Scientific Title

NOboRi biolimus A9-Eluting stent for right Coronary OstIum Lesion (NO RECOIL) registry

Scientific Title:Acronym

NO RECOIL registry

Region

Japan


Condition

Condition

Angina pectoris

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of NOBORI stent for right coronary artery ostial lesion

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

MACE (Cardiac death, Q-waveMI, Target lesion revascularization, Target vessel revascularization) at 12 month

Key secondary outcomes

1) Inhospital MACE
2) Cardiac death at 12 month
3) Myocardial infarction at 12 month
4) Target lesion revascularization at 12 month
5) Target vessel revascularization at 12 month


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

NOBORI Biolimus A9-eluting stent

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) Significant stenosi at right coronary artery ostial (within 10mm from ostial)
2) Vessel diameter > 2.5mm
3)

Key exclusion criteria

1) Right coronary artery in which other drug-eluting stent has been implanted.
2) Myocardial infarction within 7 days
3) Chronic total occlusion
4) Female with pregnant
5) Chronic renal failure (SCr.3.0)
6) Patients with malignant diseases

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Oikawa and Shinichi Shirai

Organization

The cardiovascular institute hospital
Kokura memorial hospital

Division name

Cardiology

Zip code


Address

3-2-19 Nishiazabu, Minato-ku, Tokyo, Japan

TEL

+81334082159

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kenya Nasu

Organization

Toyohashi Heart Center

Division name

Cardiology

Zip code


Address

21-1 Gobutori, O-yama cho, Toyohashi, Aichi, Japan

TEL

+81532-37-3377

Homepage URL


Email

yuyatomoya@gmail.com


Sponsor or person

Institute

The society of lipid lowering therapy

Institute

Department

Personal name



Funding Source

Organization

The society of lipid lowering therapy

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

Toyohashi Heart Center (Aichi)
Kokura Memorial Hospital (Fukuoka)
The cardiovascular institute hospital (Tokyo)
Engaru Kosei hospital (Hokkaido)
Ayase Cardiovascular hospital (Tokyo)
Matsumoto Kyoritu Hospital (Nagano)
Hoshi general hospital (Fukushima)
Rinku general hospital (Osaka)


Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 20 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

Open public recruiting

Date of protocol fixation

2011 Year 08 Month 30 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2012 Year 12 Month 01 Day

Date of closure to data entry

2013 Year 12 Month 01 Day

Date trial data considered complete

2013 Year 12 Month 01 Day

Date analysis concluded

2014 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 06 Month 14 Day

Last modified on

2012 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009617


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name