UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045982 |
|---|---|
| Receipt number | R000050730 |
| Scientific Title | Evaluation of clinical outcome after endovascular therapy for femoropopliteal artery disease in Kanagawa |
| Date of disclosure of the study information | 2021/11/05 |
| Last modified on | 2021/11/05 00:05:04 |
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Basic information
Public title
Evaluation of clinical outcome after endovascular therapy
for femoropopliteal artery disease in Kanagawa
Acronym
Landmark Registry
Scientific Title
Evaluation of clinical outcome after endovascular therapy
for femoropopliteal artery disease in Kanagawa
Scientific Title:Acronym
Landmark Registry
Region
| Japan |
Condition
Condition
peripheral artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the actual condition of EVT treatment in the femoral popliteal artery lesion, and clarify the patient's background factors, treatment content, treatment results, and factors that influence outcomes in a multicenter anterior-posterior observational study.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary patency
Key secondary outcomes
TLR: target lesion revascularization
MACLE: MACE(major adverse cardiovascular event)+MALE(major adverse limb event)
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 with stenotic or arteriosclerosis obliterans with superficial femoral artery lesions (Rutherford classification 2-6). However, acute (within 7 days) and subacute (within 1 month) lower limb ischemia cases are excluded.
(2) Age: 20 years or older (at the time of EVT treatment for femoral popliteal artery lesions)
(3)Gender: No matter
(4) Patients who can be observed for at least 12 months after EVT
(5)Patients who underwent EVT for femoral popliteal artery lesions between July 1, 2017 and June 30, 2020
Key exclusion criteria
(1)Patients who are bleeding or have a tendency to bleed
(Hemophilia, capillary fragility, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract bleeding, hemoptysis, etc.)
(2)Pregnant women or patients who may be pregnant
(3)Patients with acute / subacute lower limb ischemia
(4) Patients with a life expectancy of 1 year or less
(5)Patients who have difficulty in going to the hospital due to referral from a distance
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Mori |
Organization
Saiseikai Yokohama City Eastern Hospital
Division name
Cardiology
Zip code
230-8765
Address
3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-576-3000
hello_morisun@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Mori |
Organization
Saiseikai Yokohama City Eastern Hospital
Division name
Cardiology
Zip code
230-8765
Address
3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-576-3000
Homepage URL
hello_morisun@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Yokohama City Eastern Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohama City Eastern Hospital
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
Saiseikai Yokohama City Eastern Hospital Ethics Committee
Address
3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
Tel
045-576-3000
kenkyubango@tobu.saiseikai.or.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 | 11 | Month | 05 | 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
1378
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
| 2019 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective observational study
Management information
Registered date
| 2021 | Year | 11 | Month | 05 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050730
