UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016578 |
|---|---|
| Receipt number | R000019225 |
| Scientific Title | Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions: A comparative analysis of quantitative vessel angiography and intravascular ultrasound and computed tomography |
| Date of disclosure of the study information | 2015/02/23 |
| Last modified on | 2016/03/13 15:23:17 |
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Basic information
Public title
Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions: A comparative analysis of quantitative vessel angiography and intravascular ultrasound and computed tomography
Acronym
Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions
Scientific Title
Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions: A comparative analysis of quantitative vessel angiography and intravascular ultrasound and computed tomography
Scientific Title:Acronym
Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions
Region
| Japan |
Condition
Condition
Peripheral arterial disease (PAD)
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation about accuracy of quantitative vessel angiography (QVA) during endovascular treatment for femoropopliteal lesions
Basic objectives2
Others
Basic objectives -Others
Evaluation about accuracy of parameters measured by QVA
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Differences of vessel diameters measured by QVA and intravascular ultrasound (IVUS).
2. Differences of stent length measured by QVA, CT and IVUS.
Key secondary outcomes
Relationship between distance from calibration point and each accuracy
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
1.Age>=20, male or female.
2.Getting informed consent form a patient or legal guardian.
3.Rutherford classification category 2-6 (including critical limb ischemia) and significant stenotic lesion in the femoropopliteal artery.
4.Patient scheduled to receive stent implantation.
5.Patient who already received stent implantation, and scheduled to receive endovascular therapy.
Key exclusion criteria
1. Previous history of allergy to contrast materials and materials used in the investigational device.
2. Estimated glomerular filtrateion rate is less than 30ml/min/1.73m2. Hemodialysis patient are not excluded.
3. Patient who is determined to be unsuitable for this study by principal investigator or subinvestigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Mori |
Organization
Saiseikai Yokohama City Eastern Hospital
Division name
Cardiology
Zip code
Address
3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa.
TEL
045-576-3000
hello_morisun@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Mori |
Organization
Saiseikai Yokohama City Eastern Hospital
Division name
Cardiology
Zip code
Address
3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa.
TEL
045-576-3000
Homepage URL
hello_morisun@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiology, Saiseikai Yokohama City Eastern Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
済生会横浜市東部病院
Saiseikai Yokohama City Eastern Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 23 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Evaluation about accuracy of quantitative vessel angiography (QVA) during endovascular treatment for femoropopliteal lesions
Management information
Registered date
| 2015 | Year | 02 | Month | 18 | Day |
Last modified on
| 2016 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019225
