UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007363
Receipt number R000008672
Scientific Title Retrospective Comparative ANAlysis of the RevascuLarization Method for Infra-Inguinal Arterial Disease, Surgical reconstruction and Endovascular Treatment
Date of disclosure of the study information 2012/02/24
Last modified on 2012/02/23 10:54:41

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Basic information

Public title

Retrospective Comparative ANAlysis of the RevascuLarization Method for Infra-Inguinal Arterial Disease, Surgical reconstruction and Endovascular Treatment

Acronym

ReCANALISE

Scientific Title

Retrospective Comparative ANAlysis of the RevascuLarization Method for Infra-Inguinal Arterial Disease, Surgical reconstruction and Endovascular Treatment

Scientific Title:Acronym

ReCANALISE

Region

Japan


Condition

Condition

peripheral artery disease

Classification by specialty

Cardiology Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the prognosis of limb and life after surgical or endovascular recanalization.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

primary patency

Key secondary outcomes

assisted-primary patency, secondary patency, overall survival, limb salvage rate, major adverse cardiovascular events


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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with de novo infrainguinal artery sdisease who received surgical or endovascular recanalisation

Key exclusion criteria

restenosis
history of revasculaization
acute onset limb ischemia

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshimitsu Soga

Organization

Kokura Memorial Hospital

Division name

Department of cardiology

Zip code


Address

3-2-1 Asano Kokurakita-ku Kitakyushu Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kokura Memorial Hospital

Division name

Department of cardiology

Zip code


Address


TEL

093-511-2000

Homepage URL


Email



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

2012 Year 02 Month 24 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 10 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry

2012 Year 02 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Participant 6 institutes


Management information

Registered date

2012 Year 02 Month 23 Day

Last modified on

2012 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008672


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name