UMIN-CTR Clinical Trial

Public title

An Observational prospective Multicenter registry study on Outcomes of peripheral arTErial disease patieNts treated by AngioplaSty tHerapy in aortoIliac artery

Acronym

OMOTENASHI Registry

Scientific Title

An Observational prospective Multicenter registry study on Outcomes of peripheral arTErial disease patieNts treated by AngioplaSty tHerapy in aortoIliac artery

Scientific Title:Acronym

OMOTENASHI Registry

Region

Japan

Condition

Peripheral artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To elucidate safety and efficacy of endovascular treatment(EVT)with self-expandable or balloon expandable stents in peripheral artery disease (PAD) patients with iliac artery lesions in Japan.
To clarify current iliac artery EVT procedures and to elucidate outcomes of PAD in patients treated in today's healthcare environment (older patients, drug therapy patients).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Primary efficacy endpoints
-Primary patency rate of target vessel 12 months after index treatment
-Primary and secondary patency rate of target vessel at 3 years after index treatment
Primary safety endpoints
-Major adverse events (MAE) occurring within 30 days after index treatment. MAE is defined as death, myocardial infarction (Q-wave and non-Q-wave), stroke, TVR, or major amputation of index limb.
-MACE at 3 years after index treatment

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients diagnosed with PAD
2)Patients aged 20 years or older when providing consent
3)Patients providing written consent indicating understanding of and agreement to participate in the study, and willing to undergo follow up at 30 days, 6 months, and 1, 2, and 3 years after index treatment
4)Patients with an index limb ABI equal to or lower than 0.9, or definite diagnosis of PAD in accordance with ACCF/AHA guidelines if ABI is greater than 0.9.
5)Patients with iliac artery restenosis equal to or greater than 50%
6)Patients approved for treatment with aortoiliac stents
7)Patients classified as Rutherford class 2-4

Key exclusion criteria

1)Terminally ill patients expected to live less than one year
2)Restenosis from previous aortoiliac EVT
3)Patients considered likely to experience acute limb ischemia or acute thrombosis within one week of enrollment
4)Patients who have received EVT or vascular surgery within 30 days prior to treatment
5)Patients with untreated coagulation or significant bleeding disorders
6)Patients unable to receive anticoagulation or antiplatelet treatment
7)Patients who are or may be pregnant or lactating
8)WIQ and QOL questionnaires
9)Patients whose treatment side leg has already been amputated above the ankle
10)to participate in other clinical trials that could possible affect the scientific validity of this study

Target sample size

1500

Name of lead principal investigator

1st name	Masato
Middle name
Last name	Nakamura

Organization

Toho University, Ohashi Medical Center

Division name

Division of Cardiovascular Medicine

Zip code

153-8515

Address

2-17-6 Ohashi, Meguro-ku, Tokyo, 153-8515, Japan

TEL

+81334681251

Email

masato@oha.toho-u.ac.jp

Name of contact person

1st name	Kaori
Middle name
Last name	Shimogama

Organization

Japan Endovascular Treatment Conference

Division name

Office of OMOTENASHI Registry

Zip code

814-0006

Address

7F, Fukuoka International College of Health and Welfare, 3-6-40,Momochihama, Sawara-ku, Fukuoka-shi,

TEL

03-3468-1251

Homepage URL

http://www.omotenashi-registry.jp/

Email

secretariat@j-et.jp

Institute

Research group on endovascular treatment in aortiliac artery

Institute

Department

Personal name

Organization

Research group on endovascular treatment in aortiliac artery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research review board of Toho University Ohashi Medical Center

Address

2-22-36 Ohashi Meguro-ku Tokyo 153-8515 JAPAN

Tel

0334681251

Email

ohashi.rinri@ext.toho-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2014

Year

03

Month

28

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective study

Registered date

2014

Year

04

Month

30

Day

Last modified on

2023

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016051