UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014759
Receipt number R000017157
Scientific Title A Prospective, Multi-center, Three Year Follow-up Study on Endovascular Treatment for Infra-inguinal Vessel in patients with critical limb ischemia.
Date of disclosure of the study information 2014/08/04
Last modified on 2014/08/04 16:17:54

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Basic information

Public title

A Prospective, Multi-center, Three Year Follow-up Study on Endovascular Treatment for Infra-inguinal Vessel in patients with critical limb ischemia.

Acronym

OLIVE 3year follow-up study

Scientific Title

A Prospective, Multi-center, Three Year Follow-up Study on Endovascular Treatment for Infra-inguinal Vessel in patients with critical limb ischemia.

Scientific Title:Acronym

OLIVE 3year follow-up study

Region

Japan


Condition

Condition

Patients with peripheral artery disease (PAD) associated with critical limbs ischemia (CLI)

Classification by specialty

Cardiology Vascular surgery Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical efficacy and safety of EVT (Endovascular Treatment) in infra-inguinal vessel in patients with critical limb ischemia. For EVT, medical devices clinically reimbursable in Japan are to be used.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate free of major lower limb amputation at two years and three years after the EVT. This means that a patient survives without undergoing major lower limb amputation.

Key secondary outcomes


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

229 patients who were of the 312 patients eligible for statistical analysis of OLIVE Registry conducted from December 2009 to August 2012 and were confirmed as alive at one year after initial EVT.

Key exclusion criteria

Patients who dose not give informed consent.

Target sample size

229


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name 1) Masato Nakamura, 2) Osamu Iida

Organization

1)Toho University Ohashi Medical Center
2)Kansai Rosai Hospital

Division name

1)cardiovascular internal medicine, 2)division of cardiovascular disease

Zip code


Address

1)2-17-6 Ohashi, Meguro-ku, Tokyo, 2)3-1-69 Inabaso, Amagasaki-shi, Hyogo

TEL

03-3468-1251

Email

masato@oha.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Iida

Organization

Kansai Rosai Hospital

Division name

division of cardiovascular disease

Zip code


Address

3-1-69 Inabaso, Amagasaki-shi, Hyogo

TEL

06-6416-1221

Homepage URL


Email

iida.osa@gmail.com


Sponsor or person

Institute

OLIVE Registry Study Group

Institute

Department

Personal name



Funding Source

Organization

Associations for Establishment of Evidence in Interventions

Organization

Division

Category of Funding Organization

Non profit foundation

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

2014 Year 08 Month 04 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

2012 Year 01 Month 17 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 17 Day

Last follow-up date

2014 Year 06 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information


Management information

Registered date

2014 Year 08 Month 04 Day

Last modified on

2014 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017157


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name