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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002830
Receipt No. R000003287
Scientific Title Endovascular Treatment for Infra-inguinal Vessel, in patients with critical limb ischemia, - A Prospective, Multi-center, 12 month follow-up Registry in Japan -
Date of disclosure of the study information 2009/12/02
Last modified on 2012/12/10

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Basic information
Public title Endovascular Treatment for Infra-inguinal Vessel, in patients with critical limb ischemia, - A Prospective, Multi-center, 12 month follow-up Registry in Japan -
Acronym OLIVE Registry
Scientific Title Endovascular Treatment for Infra-inguinal Vessel, in patients with critical limb ischemia, - A Prospective, Multi-center, 12 month follow-up Registry in Japan -
Scientific Title:Acronym OLIVE Registry
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 12 months 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 a.Patients who can provide an informed consent and are aged 20 years or older when providing the consent
b.CLI has been diagnosed, and revascularization with EVT is indicated.
c.Revascularization in infra-popliteal arteries with EVT was conducted or was to be conducted.
d.Follow-up for one year or longer is considered feasible.
Key exclusion criteria << Exclusion criteria for patients >>
e.Patients with any limb which has already undergone major amputation due to ischemic disease
f.Patients with CLI in both limbs in which ischemic ulcer or gangrene is observed.
g.Patients who are considered to have the life expectancy of one year or shorter.
h.Patients in whom QOL evaluation is difficult due to dementia or the other reason.
i.Patients who may not allow long-term follow-up
<< Exclusion criteria for the affected limb >>
j.Affected limbs in which ischemic ulcer or gangrene widely spreads beyond the tarsometatarsal region
k.Affected limbs which have undergone EVT in the lower limb arteries including the abdominal aorta and iliac artery and/or femoral artery in the affected limb for the last four weeks
l.Affected limbs which are to undergo EVT as pre-treatment of the major lower limb amputation, or of which the major lower limb amputation is considered inevitable regardless of EVT practice.
m.Affected limbs which have undergone EVT in the abdominal aorta or iliac artery concurrently with EVT in the infra-inguinal arteries
Target sample size 300

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

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

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 カレスサッポロ 時計台記念病院(北海道)、厚生会 仙台厚生病院(宮城県)、信州大学医学部附属病院(長野県)、東邦大学医療センター大橋病院(東京都)、菊名記念病院(神奈川県)、恩賜財団 済生会横浜市東部病院(神奈川県)、関西労災病院(兵庫県)、徳洲会 岸和田徳洲会病院(大阪府)、浅ノ川 金沢循環器病院(石川県)、神戸大学医学部付属病院(兵庫県)、兵庫医科大学病院(兵庫県)、あかね会 土谷総合病院(広島県)、小倉記念病院(福岡県)、近江八幡市立総合医療センター(滋賀県)、慈恵会 新須磨病院(兵庫県)、大垣市民病院(岐阜県)、天神会 新古賀病院(福岡県)、福岡赤十字病院(福岡県)、総合病院松山赤十字病院(愛媛県)、国立岩国医療センター(山口県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2012 Year 08 Month 02 Day
Date of closure to data entry
2012 Year 08 Month 13 Day
Date trial data considered complete
2012 Year 08 Month 21 Day
Date analysis concluded
2012 Year 09 Month 28 Day

Other
Other related information Of patients with PAD associated with CLI, EVT indicated patients who have undergone revascularization or an attempt thereof for the infra-inguinal vessel by EVT using a commercially available medical device are registered, and follow-up survey is conducted 1, 3, 6, and 12 months after the procedure regardless of its success or failure. Items to be examined include death, major lower limb amputation, alleviation of ischemic symptoms and various ischemic indices, patency rate of the vessel subjected to EVT, and serious adverse events. In addition, changes in QOL score are to be examined.

Management information
Registered date
2009 Year 12 Month 02 Day
Last modified on
2012 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003287

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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