UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023642 |
|---|---|
| Receipt number | R000027226 |
| Scientific Title | Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2020/03/05 14:06:52 |
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Basic information
Public title
Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion
Acronym
Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion
Scientific Title
Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion
Scientific Title:Acronym
Optimal Sizing of Self-expanding Paclitaxel-eluting Stent for the Superficial Femoral Artery Lesion
Region
| Japan |
Condition
Condition
Arteriosclerosis Obliterans: ASO
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal stent diameter in the treatment for the superficial femoral artery lesion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lumen area assessed by OFDI at 6-month follow-up
Key secondary outcomes
Minimum lumen diameter assessed by angiography at 6-month follow-up.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation of stent with a 1mm larger diameter than the reference vessel
Interventions/Control_2
Implantation of stent with a 2mm larger diameter than the reference vessel
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 superficial femoral artery lesion
Key exclusion criteria
History of previous bypass surgery or previous stenting in the target lesion
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, 663-8501, Japan
TEL
0798-45-6553
hpxkg043@ybb.ne.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, 663-8501, 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
Division of Cardiovascular Medicine and Coronary Heart Disease
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
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
40
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 16 | 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=R000027226
