UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026968 |
|---|---|
| Receipt number | R000030922 |
| Scientific Title | A prospective multicenter registry on outcomes of endovascular treatment in patients with atherosclerotic femoropopliteal artery disease in Japan |
| Date of disclosure of the study information | 2017/04/12 |
| Last modified on | 2021/10/18 15:07:39 |
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Basic information
Public title
A prospective multicenter registry on outcomes of endovascular treatment in patients with atherosclerotic femoropopliteal artery disease in Japan
Acronym
Guide SFA
Scientific Title
A prospective multicenter registry on outcomes of endovascular treatment in patients with atherosclerotic femoropopliteal artery disease in Japan
Scientific Title:Acronym
Guide SFA
Region
| Japan |
Condition
Condition
Patients with symptomatic PAD with lesions in femoropopliteal artery who have elected to receive endovascular treatment.
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This registry is designed as a prospective, multicenter, observational study for Japanese patients with symptomatic peripheral artery disease (PAD) caused by lesions in superficial femoral artery and/or proximal popliteal artery (PPA). The objective of the study is to establish the safety and effectiveness of endovascular treatment (EVT) in the real world under current medical environment in Japan, and to obtain fundamental data such as usage of medical devices and medications for further improvement of PAD treatment. In the study, EVT will be performed using any SFA/PPA devices marketed in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Freedom from Target Vessel Revascularization (TVR)in the index limb at 1 and 2 year(s)
Key secondary outcomes
Improvement of walking ability measured by means of WIQ or a medical interview, MAE within 30days after index procedure, EVT procedure related adverse events
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
Informed consent to being a subject of this study and agreeing to undergo follow-up examinations at 30 days, and 1 and 2 years after receiving EVT.
Key exclusion criteria
1) Planned bypass surgery or major amputation within 30 days after EVT, 2) Life expectancy of less than two years, 3) Acute limb ischemia (ALI), 4) Anti-thrombotic treatment is not applicable.
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nakamura |
Organization
Toho University Ohashi Medical Center
Division name
Cardiovascular internal medicine
Zip code
153-8515
Address
2-17-6 Ohashi, Meguro-ku, Tokyo, 153-8515, Japan
TEL
0334681251
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 Guide SFA Registry
Zip code
814-0001
Address
7F, Fukuoka International College of Health and Welfare, 3-6-40, Momochihama, Sawara-ku, Fukuoka-shi
TEL
03-3468-1251
Homepage URL
guide-sfa.registry@j-et.jp
Sponsor or person
Institute
Japan Endovascular Treatment Conference
Office of Guide SFA Registry
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific
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
Toho University, Oahshi Medical Center
Address
2-22-36 Ohashi Meguroku Tokyo 153-8515 Japan
Tel
0334681251
masato@oha.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
| 2017 | Year | 04 | Month | 12 | 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
1003
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
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective registry
Management information
Registered date
| 2017 | Year | 04 | Month | 12 | Day |
Last modified on
| 2021 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030922
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
