UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002830 |
|---|---|
| Receipt number | 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 15:04:27 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003287
