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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008433
Receipt No. R000009885
Scientific Title ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy. -Prospective multicenter registry-
Date of disclosure of the study information 2012/07/13
Last modified on 2017/10/13

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Basic information
Public title ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy.
-Prospective multicenter registry-
Acronym ZEPHYR Registry
Scientific Title ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy.
-Prospective multicenter registry-
Scientific Title:Acronym ZEPHYR Registry
Region
Japan

Condition
Condition Peripheral artery disease
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate the efficacy and safety of endovascular therapy combined with drug eluting stent in patients with symptomatic peripheral arterial disease and femoropopliteal obstructions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes One-year restenosis rates
Key secondary outcomes 1) All-cause mortality
2) CAD
3) MI
4) Stroke
5) Freedom from TVR
6) Surgical conversion rates
7) MLower-limb Major amputation rates
8) Technical complications of EVT
9) in-stent thrombosis
10) Bleeding complications

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 Symptomatic patients with peripheral artery disease due to Femoro-popliteal arterial lesions
Key exclusion criteria 1) life expectancy <1 yrs
2) unsuccessful angioplasty
3) residual inflow lesion
4) ALI
5) active bleeding
6) allergy for nitinol
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1) Osamu Iida, 2) Hiroyoshi Yokoi
Organization 1) Kansai Rosai Hospital
2) Kokura Memorial Hospital
Division name 1) Cardiovascular Center, 2) department of cardiology
Zip code
Address 1) 3-1-69 Inabaso, Amagasaki-shi, Hyogo, 2) 3-2-1 Asano Kokurakita-ku kitakyushu
TEL 06-6416-1221
Email iida.osa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Iida
Organization Kansai Rosai Hospital
Division name Cardiovascular Center
Zip code
Address 3-1-69 Inabaso, Amagasaki-shi, Hyogo
TEL 06-6416-1221
Homepage URL
Email iida.osa@gmail.com

Sponsor
Institute ZEPHYR Study Group
Institute
Department

Funding Source
Organization ZEPHYR Study Group
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
Address
Tel
Email

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 旭川医科大学病院、近江八幡市立総合医療センター、金沢医科大学病院、関西労災病院、菊名記念病院、京都大学医学部附属病院、神戸労災病院、小倉記念病院、三田市民病院、新古賀病院、信州大学医学部附属病院、仙台厚生病院、東海大学医学部付属病院、榊原記念病院東邦大学医療センター大橋病院、彦根市立病院、兵庫医科大学病院、福岡赤十字病院、松山赤十字病院、山形大学医学部附属病院、済生会横浜市東部病院、遠軽厚生病院

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1-year restenosis rate 37%
Restnotic factors
1) lesion length, 2) vessel diameter, 3) minimum stent area
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 Completed
Date of protocol fixation
2012 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Result was published in JACCintervention

Management information
Registered date
2012 Year 07 Month 13 Day
Last modified on
2017 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009885

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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