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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013849
Receipt No. 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 2017/04/27

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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
Middle name
Last name Masato Nakamura
Organization Toho University, Ohashi Medical Center
Division name Division of Cardiovascular Medicine
Zip code
Address 2-17-6 Ohashi, Meguro-ku, Tokyo, 153-8515, Japan
TEL 03-3468-1251
Email masato@oha.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaori Shimogama
Organization Japan Endovascular Treatment Conference
Division name Office of OMOTENASHI Registry
Zip code
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
Institute Research group on endovascular treatment in aortiliac artery
Institute
Department

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
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

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
2017 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.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


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