UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013849
Receipt number R000016051
Scientific Title An Observational prospective Multicenter registry study on Outcomes of peripheral arTErial disease patieNts treated by AngioplaSty tHerapy in aortoIliac artery
Date of disclosure of the study information 2014/05/01
Last modified on 2023/11/06 14:30:15

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Basic information

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

Condition

Peripheral artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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



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

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Research group on endovascular treatment in aortiliac artery

Institute

Department

Personal name



Funding Source

Organization

Research group on endovascular treatment in aortiliac artery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

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

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 05 Month 01 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

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

Other related information

Prospective study


Management information

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name