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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043721
Receipt No. R000049917
Scientific Title COnteMporary strategy For aORToiliac intervention registry
Date of disclosure of the study information 2021/03/24
Last modified on 2021/09/22

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Basic information
Public title COnteMporary strategy For aORToiliac intervention registry
Acronym COMFORT Registry
Scientific Title COnteMporary strategy For aORToiliac intervention registry
Scientific Title:Acronym COMFORT Registry
Region
Japan

Condition
Condition Patients with peripheral artery disease (PAD) associated with AI: aorto-iliac
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the initial result of endovascular therapy (EVT) in peripheral artery disease (PAD) patients with aorto-iliac lesions and explore related factors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Procedure success
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) 20 years or older
2) Symptomatic peripheral artery disease
3) Enable to undergo follow up at 30 days after index treatment
Key exclusion criteria 1) patients in whom surgical reconstruction and/or major amputation within 30 days after endovascular therapy are scheduled.
2) Acute limb ischemia
3) Prior history of surgical reconstruction and/or major amputation
(either ipsilateral or contralateral)
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Osamu
Middle name
Last name Iida
Organization Kansai Rosai Hospital
Division name Cardiovascular center
Zip code 660-8511
Address 3-1-69 Inabaso, Amagasaki, Hyogo, 660-8511,Japan
TEL 06-6416-1221
Email iida.osa@gmail.com

Public contact
Name of contact person
1st name Kaori
Middle name
Last name Shimogama
Organization Japan Endovascular Treatment Conference
Division name Office of COMFORT Registry
Zip code 814-0001
Address M-TOWER 11F, 1-7-5 Momochihama, Sawara-ku, Fukuoka 814-0001, Japan
TEL 092-834-2815
Homepage URL
Email secretariat@j-et.jp

Sponsor
Institute Japan Endovascular Treatment Conference
Institute
Department

Funding Source
Organization TERUMO CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kansai Rosai Hospital Institutional Review Board
Address 3-1-69 Inabaso, Amagasaki, Hyogo, 660-8511,Japan
Tel 06-6416-1221
Email chiken@kansaih.johas.go.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
2021 Year 03 Month 24 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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 25 Day
Date of IRB
2020 Year 12 Month 22 Day
Anticipated trial start date
2021 Year 01 Month 24 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective registry

Management information
Registered date
2021 Year 03 Month 23 Day
Last modified on
2021 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049917

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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