UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015485 |
|---|---|
| Receipt number | R000017996 |
| Scientific Title | Impact of Stent Diameter on Vascular Response After Self-expanding Paclitaxel-eluting Stent Implantation in the Superficial Femoral Artery: An Optical Frequency Domain Imaging Study |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2017/07/11 11:43:54 |
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Basic information
Public title
Impact of Stent Diameter on Vascular Response After Self-expanding Paclitaxel-eluting Stent Implantation in the Superficial Femoral Artery: An Optical Frequency Domain Imaging Study
Acronym
Optimal Diameter of Self-expanding Paclitaxel-eluting Stent in the Superficial Femoral Artery
Scientific Title
Impact of Stent Diameter on Vascular Response After Self-expanding Paclitaxel-eluting Stent Implantation in the Superficial Femoral Artery: An Optical Frequency Domain Imaging Study
Scientific Title:Acronym
Optimal Diameter of Self-expanding Paclitaxel-eluting Stent in the Superficial Femoral Artery
Region
| Japan |
Condition
Condition
Peripheral Artery Disease
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyse the optimal stent diameter of self-expanding paclitaxel-eluting stent in the superficial femoral artery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lumen volume 6 months after self-expanding paclitaxel-eluting stent implantation
Key secondary outcomes
Neointimal volume 6 months after self-expanding paclitaxel-eluting stent implantation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
paclitaxel-eluting stent implantation with the diameter of 6mm
Interventions/Control_2
paclitaxel-eluting stent implantation with the diameter of 8mm
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
PAD patients with isolated SFA lesion (length less than 150mm)
Key exclusion criteria
Patients with in-flow or out-flow disease
Restenotic lesions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaharu Ishihara |
Organization
Hyogo College of Medicine
Division name
Division of Coronary Heart Disease
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya-city, Hyogo, 6638501, Japan
TEL
0798456553
hpxkg043@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kojiro Miki |
Organization
Hyogo College of Medicine
Division name
Cardiovascular Division
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya-city, Hyogo, 6638501, Japan
TEL
0798456553
Homepage URL
hpxkg043@ybb.ne.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Cook Japan
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 21 | Day |
Last modified on
| 2017 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017996
