UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045937 |
|---|---|
| Receipt number | R000052377 |
| Scientific Title | Two-year results of endovascular treatment for femoropopliteal artery disease in Japan during the introduction of drug-eluting devices. Registry of multicenter endovascular treatment for superficial femoral artery and popliteal artery disease |
| Date of disclosure of the study information | 2021/10/30 |
| Last modified on | 2021/10/30 23:00:19 |
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Basic information
Public title
Registry of multicenter endovascular treatment for superficial femoral
artery and popliteal artery disease
Acronym
GUIDE SFA
Scientific Title
Two-year results of endovascular treatment for femoropopliteal artery disease in Japan during the introduction of drug-eluting devices.
Registry of multicenter endovascular treatment for superficial femoral
artery and popliteal artery disease
Scientific Title:Acronym
GUIDE SFA
Region
| Japan |
Condition
Condition
Peripheral arterial disease: PAD
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to build preliminary data of Japanese femoropopliteal lesions in a period of transition from non-drug to drug technology
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy endpoint was freedom from clinically-driven target lesion revascularization and improvement of maximum walking distance at 1-year and 2-year.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were as follows: (i) symptomatic patients with peripheral arterial disease and femoropopliteal lesions, (ii) patient availability for at least a 1-year follow-up after EVT, and (iii) Rutherford classification from grade 2 to grade 5.
Key exclusion criteria
Exclusion criteria were as follows: (1) scheduled major amputation, (2) acute limb ischemia, (3) difficulty in using contrast media and antiplatelet agents, (4) isolated P3 lesion, and (5) dementia
Target sample size
1003
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Saiseikai Central Hospital
Division name
Cardiology
Zip code
1080073
Address
1-4-17, Mita, Minato, Tokyo
TEL
03-3451-8211
k-y.suzuki@nifty.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Suzuki |
Organization
Japan Endovascular Treatment Conference
Division name
Program committee
Zip code
8140001
Address
1-7-5, Momochiha, Sawara, Fukuoka
TEL
092-834-2815
Homepage URL
k-y.suzuki@nifty.com
Sponsor or person
Institute
Japan Endovascular Treatment Conference
Institute
Department
Personal name
Funding Source
Organization
Japan Endovascular Treatment Conference
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Saiseikai Central Hospital IRB
Address
1-4-17, Mita, Minato, Tokyo
Tel
0334518211
k-y.suzuki@nifty.com
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 | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Presentation was opened by JET2021
Management information
Registered date
| 2021 | Year | 10 | Month | 30 | Day |
Last modified on
| 2021 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052377
