UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006032
Receipt number R000007141
Scientific Title REtrospective multicentre AnaLysis for Aorto-Iliac stenting
Date of disclosure of the study information 2011/07/25
Last modified on 2011/10/03 14:24:02

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Basic information

Public title

REtrospective multicentre AnaLysis for Aorto-Iliac stenting

Acronym

REAL-AI

Scientific Title

REtrospective multicentre AnaLysis for Aorto-Iliac stenting

Scientific Title:Acronym

REAL-AI

Region

Japan


Condition

Condition

Aortoiliac artery disease

Classification by specialty

Cardiology Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Safety and efficacy of primary stenting for aortoiliac artery disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

primary patency

Key secondary outcomes

secondary patency
initial success rate, mortality, non-fatal myocardial infarction, stroke, amputation rate, revascularization rate


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Between January 2005 and Descenber 2009, elective primary stenting for de novo aortoiliac lesion.

Key exclusion criteria

acute onset
rstenotic lesion
history of recanalization
asymptomatic
treatment by balloon angioplasty alone

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshimitsu Soga

Organization

Kokura Memorial Hospital

Division name

cardiology

Zip code


Address

3-2-1 Asano Kokurakita-ku Kitakyushu city Japan

TEL

+81935112000

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kokura Memorial Hospital

Division name

cardiology

Zip code


Address


TEL


Homepage URL


Email

kmhptca@kokura-heart.com


Sponsor or person

Institute

Kokura Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

Kokura Memorial 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

2011 Year 07 Month 25 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

2011 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2011 Year 08 Month 01 Day

Date of closure to data entry

2011 Year 09 Month 01 Day

Date trial data considered complete

2011 Year 10 Month 01 Day

Date analysis concluded

2011 Year 11 Month 01 Day


Other

Other related information

trial was finished


Management information

Registered date

2011 Year 07 Month 24 Day

Last modified on

2011 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007141


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name