UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012565 |
|---|---|
| Receipt number | R000014698 |
| Scientific Title | Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2017/07/11 11:44:52 |
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Basic information
Public title
Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study
Acronym
Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study
Scientific Title
Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study
Scientific Title:Acronym
Strut Coverage After Paclitaxel-Eluting Stent implantation Compared with Bare Metal Stent Implantation in the Superficial Femoral Artery: Optical Frequency Domain Imaging Study
Region
| Japan |
Condition
Condition
Peripheral Artery Disease (PAD)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the detailed vascular responses to different stent types in the superficial femoral artery lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The percentage of uncovered stent struts 6 months after stent implantation
Key secondary outcomes
Neointimal volume 6 months after 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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bare-metal nitinol stent implantation for the superficial femoral artery lesion
Interventions/Control_2
Paclitaxel-eluting nitinol stent implantation for the superficial femoral artery lesion
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
Patients planned endovascular therapy with self-expanding stent for the de novo superficial femoral artery lesions (less than 15cm) in Hyogo College of Medicine
Key exclusion criteria
1)Lesions with previous stent implantation
2)Lesions with previous FP-bypass
3)Acute or subacute limb ischemia
4)Patients without tolerance for antiplatelet agents
5)Patients without written informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Masuyama |
Organization
Hyogo College of Medicine
Division name
Cardiovascular Division
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
Cardiovascular Division, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Division, 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
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
兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | 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
| 2013 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 12 | 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=R000014698
