UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of endovascular treatment for arteriosclerosis obliterans using covered stent (I-CAST)
Title of the study (Brief title)	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	Atsuhiro Koya
Organization	Asahikawa medical university
Division name	Vascular surgery
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	Atsuhiro Koya
Organization	Asahikawa medical university
Division name	Vascular surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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