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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036798
Receipt No. R000041929
Scientific Title Real DES study -Zilver PTX vs Eluvia for femoropopliteal disease in multicenter prospective study-
Date of disclosure of the study information 2019/05/20
Last modified on 2019/05/20

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Basic information
Public title Real DES study
-Zilver PTX vs Eluvia for femoropopliteal disease in multicenter prospective study-
Acronym Real DES study
Scientific Title Real DES study
-Zilver PTX vs Eluvia for femoropopliteal disease in multicenter prospective study-
Scientific Title:Acronym Real DES study
Region
Japan

Condition
Condition Obstructive arteriosclerosis of superficial femoral artery lesion.
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compare the effectiveness and safety of
Eluvia and Zilver PTX in long-term clinical practice in Japan and explore related factors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Of the first year primary patency/secondary patency
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 old or older.
2) Atherosclerosis, with symptoms of peripheral artery disease (Rutherford Category 1 to 6).
3) Resting ABI is less than 0.9. Or, if the ABI is 0.9 or more, ischemia is evaluated in another test.
4) A stenosis evaluated by angiography or CT or MRI in the FPA area shows 50% or more or occlusion, or a stenosis or occlusion of PSVR> 2.4 in vascular echo (whether a new lesion or a restenotic lesion does not matter)
Key exclusion criteria 1) Significant constriction (50% or more) in the ipsilateral proximal CFA or iliac artery area or aorta, or unsuccessful (30% or more residual stenosis) inflowing stenosis or occlusion before this procedure . However, if simultaneous treatment (EVT for iliac and femoral arteries) is planned, entry is possible.
2) Surgical bypass surgery and major amputation are planned within 30 days after EVT.
3) Cases with untreated angiographically evident thrombi in the target lesion
4) Cases with anastomotic lesions after bypass surgery
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Shibata
Organization Hakodate Municipal Hospital
Division name Cardiovascular surgery
Zip code 041-0821
Address Minatocho 1-10-1 Hakodate Hokkaido Japan
TEL 0138-43-2000
Email shibatatsuyoshi0827@yahoo.co.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Shibata
Organization Hakodate Municipal Hospital
Division name Cardiovascular surgery
Zip code 041-0821
Address Minatocho 1-10-1 Hakodate Hokkaido Japan
TEL 0138-43-2000
Homepage URL
Email shibatatsuyoshi0827@yahoo.co.jp

Sponsor
Institute Hakodate Municipal Hospital
Institute
Department

Funding Source
Organization Hakodate Municipal Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hakodate Municipal Hospital
Address Minatocho 1-10-1 Hakodate Hokkaido Japan
Tel 0138-43-2000
Email shibatatsuyoshi0827@yahoo.co.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 総合南東北病院、水戸協同病院、釧路孝仁会病院、九州医療センター、土谷総合病院、函館五稜郭病院、春日井市民病院、京都第二赤十字病院、済生会和歌山病院、山口県立総合医療センター

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 20 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
2019 Year 02 Month 07 Day
Date of IRB
2019 Year 02 Month 07 Day
Anticipated trial start date
2019 Year 02 Month 07 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Participants'study period

Participants will participate in the 36-month observation period after agreeing

Observation and inspection items

Collect the following data.
-Patient background (gender, age, walking condition, hypertension, lipid abnormalities, diabetes, kidney disease, smoking condition, coronary artery disease, cerebrovascular disorder, heart failure, atrial fibrillation, medication status)
-Affected limb background (classification of clinical severity (Rutherford classification), ABI (ankle-brachial index), degree of calcification (PACSS Grade), run-off number of peripheral arteries)
-Lesion background, angiography evaluation (TASC II Classification, lesion, vascular diameter, lesion type, stenosis, lesion length, occlusion length, calcification, lesion morphology, pre-placement stent (ISR, Tosaka classification), EVT pre-IVUS findings) -Treatment information (actual treatment content (puncture method, use guide wire, use device, treatment time, contrast agent amount, post-treatment vascular morphology, stent type, stent size, pre balloon diameter, pre extension time, pre extended pressure/post
Balloon diameter, Post extension time, post extended pressure))
-Lesion (subknee artery or upper knees and aortic iliac artery merger)
-PSVR of the target vessels by the lower extremity artery echo (Treatment 1.3, 6, 12 months later)
-Post-treatment information (ABI and perioperative complications after treatment)
-Tracking Survey (reason), death (cause of death), large leg cutting, surgical revascularization migration, re-treatment, ischemic ulcer healing and medication status)
-Image inspection information such as vascular imaging inspection and CT examination


Management information
Registered date
2019 Year 05 Month 20 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041929

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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