UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043721 |
|---|---|
| Receipt number | R000049917 |
| Scientific Title | COnteMporary strategy For aORToiliac intervention registry |
| Date of disclosure of the study information | 2021/03/24 |
| Last modified on | 2023/09/25 10:51:53 |
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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
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
secretariat@j-et.jp
Sponsor or person
Institute
Japan Endovascular Treatment Conference
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 25 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Prospective registry
Management information
Registered date
| 2021 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049917
