UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036499 |
|---|---|
| Receipt number | R000041580 |
| Scientific Title | Vascular Response to Implantation of Drug-eluting Stent in femoropopliteal Artery Lesions |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2019/04/22 21:52:14 |
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Basic information
Public title
Vascular Response to Implantation of Drug-eluting Stent in femoropopliteal Artery Lesions
Acronym
Vascular Response to Implantation of Drug-eluting Stent in femoropopliteal Artery Lesions
Scientific Title
Vascular Response to Implantation of Drug-eluting Stent in femoropopliteal Artery Lesions
Scientific Title:Acronym
Vascular Response to Implantation of Drug-eluting Stent in femoropopliteal Artery Lesions
Region
| Japan |
Condition
Condition
Peripheral Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate presence of intra-stent thrombus 6 months after implantation of drug-eluting stent in femoropopliteal artery lesions.
Basic objectives2
Others
Basic objectives -Others
To investigate the optimal anti-platelet therapy after implantation of drug-eluting stent in femoropopliteal artery lesions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Existence of thrombus 6 months after implantation of drug-eluting stent in femoropopliteal artery lesions
Key secondary outcomes
Neointimal proliferation at 6 months
Stent thrombosis for 1 year
Stent patency at 1 year
Bleeding events for 1 year
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anti-platelet therapy
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 femoropopliteal artery lesions
Key exclusion criteria
Patients who require long-term DAPT
Patients who require anti-coagulant therapy
In-stent restenosis
Target sample size
20
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
Zip code
663-8131
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8131, 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
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
IRB 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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041580
