UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036798
Receipt number 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 2022/05/24 19:54:02

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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 or person

Institute

Hakodate Municipal Hospital

Institute

Department

Personal name



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

2022 Year 05 Month 24 Day



Link to view the page

Value
https://center6.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