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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023408
Receipt No. R000026964
Scientific Title The study of endovascular treatment for arteriosclerosis obliterans using covered stent (I-CAST)
Date of disclosure of the study information 2016/08/15
Last modified on 2016/07/30

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Basic information
Public title The study of endovascular treatment for arteriosclerosis obliterans using covered stent (I-CAST)
Acronym The study of endovascular treatment with covered stent (I-CAST)
Scientific Title The study of endovascular treatment for arteriosclerosis obliterans using covered stent (I-CAST)
Scientific Title:Acronym The study of endovascular treatment with covered stent (I-CAST)
Region
Japan

Condition
Condition Arteriosclerosis obliterans
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Inspection of the effect of endovascular treatment using covered stent (I-CAST) on occlusive artery disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Post operative follow up period is two years. Blood exam, ABI measurement and duplex scan are included in follow up examinations at five Points (one month, three months, six months, one year and two yares) after operation, and confirm yes or no of the malfunction associated with covered stent.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 revascularization with covered stent is performed at once for each arterial lesion
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,The case with lower limbs chronic artery obstruction that it is hard to cure in the endovascular treatment with avairable present modality.
2,There are arterial stenotic lesions localized within aorta, iliac artery and femoral artery diagnosed the endovascular treatment is suitable for the revascularization.
Key exclusion criteria 1, The case who cannot visit a hospital for treatment
2,The case who has difficulty in understanding of the will
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Koya
Organization Asahikawa medical university
Division name Vascular surgery
Zip code
Address Midorigaoka-higashi2-1-1-1,Asahikawa city,Hokkaidou
TEL 0166-68-2494
Email akoya@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuhiro Koya
Organization Asahikawa medical university
Division name Vascular surgery
Zip code
Address Midorigaoka-higashi2-1-1-1,Asahikawa city, Hokkaidou
TEL 0166-68-2494
Homepage URL
Email akoya@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa medical univercity
Institute
Department

Funding Source
Organization Asahikawa medical university
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 15 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 30 Day
Last modified on
2016 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026964

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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