UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032473
Receipt number R000037028
Scientific Title ZilvER ptx with cilOstazol in Superficial femoral artery
Date of disclosure of the study information 2018/06/01
Last modified on 2022/03/13 10:15:12

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Basic information

Public title

ZilvER ptx with cilOstazol in Superficial femoral artery

Acronym

ZERO trial

Scientific Title

ZilvER ptx with cilOstazol in Superficial femoral artery

Scientific Title:Acronym

ZERO trial

Region

Japan


Condition

Condition

PAD

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

TBA

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

TBA

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

For SFA lesions
Stenting DES(Zilver PTX)
1 year oral administration of Cilostazol

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

TBA

Key exclusion criteria

TBA

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Miura

Organization

Nagano Municipal Hospital

Division name

Cardiology

Zip code

381-0006

Address

1333-1 Tomitake. Nagano, Japan 381-0006

TEL

0262951199

Email

miuramen10miuramen@yahoo.co.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Miura

Organization

Nagano Municipal Hospital

Division name

Cardiology

Zip code

381-0006

Address

1333-1 Tomitake. Nagano, Japan 381-0006

TEL

0262951199

Homepage URL


Email

miuramen10miuramen@yahoo.co.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Shinshu university Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular Medicine, Shinshu university Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagano Municipal Hospital

Address

1333-1 Tomitake. Nagano, Japan 381-0006

Tel

0262951199

Email

privacy@hospital.nagano.nagano.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

2018 Year 06 Month 01 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

No longer recruiting

Date of protocol fixation

2018 Year 03 Month 31 Day

Date of IRB

2019 Year 05 Month 24 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2021 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

no deta


Management information

Registered date

2018 Year 05 Month 05 Day

Last modified on

2022 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037028


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name