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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014759
Receipt No. 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

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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
Institute OLIVE Registry Study Group
Institute
Department

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
URL(English) https://upload.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


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