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

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 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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name