UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023768 |
|---|---|
| Receipt number | R000027384 |
| Scientific Title | Impact of Analysis Interval Size on the Quality of Intravascular Ultrasound Assessments During Stent Implantation for the Superficial Femoral Artery Lesion |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2020/03/05 12:31:02 |
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Basic information
Public title
Impact of Analysis Interval Size on the Quality of Intravascular Ultrasound Assessments During Stent Implantation for the Superficial Femoral Artery Lesion
Acronym
Impact of Analysis Interval Size on the Quality of Intravascular Ultrasound Assessments During Stent Implantation for the Superficial Femoral Artery Lesion
Scientific Title
Impact of Analysis Interval Size on the Quality of Intravascular Ultrasound Assessments During Stent Implantation for the Superficial Femoral Artery Lesion
Scientific Title:Acronym
Impact of Analysis Interval Size on the Quality of Intravascular Ultrasound Assessments During Stent Implantation for the Superficial Femoral Artery Lesion
Region
| Japan |
Condition
Condition
arteriosclerosis obliterans
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of analysis interval size on intravascular ultrasound (IVUS) assessment of stent therapy for lesions of the superficial femoral artery (SFA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Minimum stent area assessed by IVUS
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intravascular ultrasound (IVUS)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
de novo SFA lesion
Lesion scheduled to receive stent implantation
Lesion <15cm
Key exclusion criteria
Patient with a history of previous endovascular therapy
Patient with a history of previous bypass surgery
Lesion with chronic total occlusion
Intolerance of contrast media
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Ishihara |
Organization
Hyogo College of Medicine
Division name
Division of Cardiovascular Medicine and Coronary Heart Disease
Zip code
663-8131
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8131, Japan
TEL
0798-45-6553
kojiro@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Miki |
Organization
Hyogo College of Medicine
Division name
Division of Cardiovascular Medicine and Coronary Heart Disease
Zip code
663-8131
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8131, Japan
TEL
0798-45-6553
Homepage URL
hpxkg043@ybb.ne.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8131, Japan
Tel
0798-45-6066
rinri@hyo-med.ac.jp
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
兵庫医科大学病院(兵庫県)、川崎病院(兵庫県)、東宝塚さとう病院(兵庫県)、桜橋渡辺病院(大阪府)、森ノ宮病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 26 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 26 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 25 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027384
