UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045983 |
|---|---|
| Receipt number | R000052355 |
| Scientific Title | EVUS guided wiring vs. knuckle wiring for femoropopliteal chronic total occlusive lesion |
| Date of disclosure of the study information | 2021/11/05 |
| Last modified on | 2021/11/05 00:21:02 |
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Basic information
Public title
EVUS guided wiring vs. knuckle wiring for femoropopliteal chronic total occlusive lesion
Acronym
EPOCH study
Scientific Title
EVUS guided wiring vs. knuckle wiring for femoropopliteal chronic total occlusive lesion
Scientific Title:Acronym
EPOCH study
Region
| Japan |
Condition
Condition
peripheral artery disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose is to examine the short-term and long-term outcomes of new drug-eluting stents (Eluvia) in different wire routes in femoropopliteal chronic total occlusive lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary patency rate (at 1 month, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months)
Key secondary outcomes
Freedom from TLR
MACLE
Wire passage route evaluated by IVUS
Degree of dissection after balloon dilation, angiographic findings, IVUS findings
Procedure time, radiation exposure, contrast medium usage
Procedure complications
Improvement of patient symptoms by Rutherford classification
Improvement of ABI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
EVUS guided wiring
Interventions/Control_2
Knuckle wiring
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) Symptomatic PAD, including restenosis after POBA
2) Obstructive lesions in the femoral popliteal artery
3) The popliteal artery contains the P1-2 segment
4) Being 20 years old or older at the time of obtaining consent
5) Chronic limb threatening ischemia (CLTI) Rutherford Classification 4
Key exclusion criteria
1) Patients with acute lower limb ischemia or acute thrombosis
2) Patients with a history of stent placement for the target blood vessel
3) Patients with non-arteriosclerotic stenosis and obstructive lesions
4) Patients who have difficulty taking antiplatelet drugs / anticoagulants
5) Chronic limb threatening ischemia (CLTI) Rutherford classification 5 or 6
6) When the doctor in charge judges that it is inappropriate
7) Cases in which blood vessels cannot be visualized with EVUS
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Hirano |
Organization
Toyohashi Heart Center
Division name
Cardiology
Zip code
441-8530
Address
21-1, Gobutori, Oyama, Toyohashi, Aichi
TEL
0532-37-3377
keisuke.hirano.sayeh@gmail.com
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, Turumi-ku, Yokohama, Kanagawa
TEL
045-576-3000
Homepage URL
hello_morisun@yahoo.co.jp
Sponsor or person
Institute
Toyohashi heart center
Institute
Department
Personal name
Funding Source
Organization
Tokai Live Association
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
Toyohashi heart center
Address
21-1, Gobutori, Oyama, Toyohashi, Aichi
Tel
0532-37-3377
thcirb@outlook.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
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
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective 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=R000052355
