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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017996
Receipt No. R000020855
Scientific Title Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment in peripheral artery disease patients
Date of disclosure of the study information 2015/06/21
Last modified on 2015/10/13

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Basic information
Public title Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment
in peripheral artery disease patients
Acronym Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment
in peripheral artery disease patients
Scientific Title Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment
in peripheral artery disease patients
Scientific Title:Acronym Lower limb artery Calcification Assessment with Dual-Energy Multidetector CT and Impact on endovascular treatment
in peripheral artery disease patients
Region
Japan

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

Objectives
Narrative objectives1 To clarify how Lower limb artery Calcification Assessment with
Dual-Energy Multidetector CT Impacts on endovascular treatment in peripheral artery disease patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes colleration between the ratio of minimum lumen area to reference lumen area in calcified lower limb lesion after endovascular treatment and calcification assessment with Dual-Energy Multidetector CT.
Key secondary outcomes 1 Predictive values of the ratio of minimum lumen area to reference lumen area in calcified lower limb lesion after endovascular treatment in calcification assessment with Dual-Energy Multidetector CT and patients characters.
2 colleration between the ratio of long diameter to short diameter in calcified lower limb lesion after endovascular treatment and calcification assessment with Dual-Energy Multidetector CT.

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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1 patients with endovascular treatment in the lower limb artery with calcified lesions
2 patients with agreement for study
Key exclusion criteria inappropriate patients determined by study director
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Higashitani
Organization Sakakibara Heart Institute
Division name Department of Cardiology
Zip code
Address 3-16-1 asahi-cho Futyu-shi Tokyo
TEL 042-314-3111
Email mhigashi@shi.heart.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Clinical Trials Support Office
Organization Sakakibara Heart Institute
Division name Clinical Trials Support Office
Zip code
Address 3-16-1 asahi-cho Futyu-shi Tokyo
TEL 042-314-3111
Homepage URL
Email tikenjim@shi.heart.or.jp

Sponsor
Institute Japan Reserch Promotion Society for Cardiovascular disease
Institute
Department

Funding Source
Organization Sakakibara Heart Institute
Organization
Division
Category of Funding Organization Non profit foundation
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
2015 Year 06 Month 21 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 Terminated
Date of protocol fixation
2015 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 19 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1

Management information
Registered date
2015 Year 06 Month 21 Day
Last modified on
2015 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=R000020855

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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