UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023408 |
|---|---|
| Receipt number | 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 20:37:22 |
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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
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
akoya@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa medical univercity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026964
