UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018314 |
|---|---|
| Receipt number | R000021134 |
| Scientific Title | Suppression of vascular wall Healing after IMplantation of drug Eluting peripheral stent in Japanese patients with the Infra inguinal lesion: serial angioscopic observation |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2015/07/13 13:48:41 |
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Basic information
Public title
Suppression of vascular wall Healing after IMplantation of drug Eluting peripheral stent in Japanese patients
with the Infra inguinal lesion: serial angioscopic observation
Acronym
SHIMEJI trial
Scientific Title
Suppression of vascular wall Healing after IMplantation of drug Eluting peripheral stent in Japanese patients
with the Infra inguinal lesion: serial angioscopic observation
Scientific Title:Acronym
SHIMEJI trial
Region
| Japan |
Condition
Condition
arteriosclerosis obliterans
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The neoihtima coverage of stent strut and the presence or absence of thrombus attachment assessed by angioscopy 2 months, 6 months, and 12 months after drug-eluting stent implantation for superficial femoral artery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Angioscopic findings
1. The presence of absence of thrombus attachment
2. Dominant of neointimal coverage grade
Key secondary outcomes
Angioscopid findings
1. The color of thrombus (categorized as red, white, and mixed thrombus)
2. Quantitative assessment of thrombus (0-10%, 10-50%, and >50%)
3. Neointima distribution
4. Color and character of vessel wall at stenting site
5. The presence or absence of yellow plaque and quantitative assessment of yellow plaque (0-10%, 10-50%, and >50%)
6. The presence or absence of erosion and dissection
Cardiovascular events
1. Cardiac death
2. Cerebral infarction
3. Myocardial infarction
5. Stent thrombosis (Definit or probable based on ARC definition)
6. Revascularization (UTVR, TVT, TLR)
Safety
1. Major bleeding (symptomatic intracranial hemorrhage and fatal bleeding)
2. Gastrointestinal and mucosal bleeding
3. Adverse event
Pharmacodynamic assessment
1. The relationship between angioscopic findings and platelet aggregation assessed by Verify NOW.
2. The relationship between CYP2C19 polymorphism and drug efficacy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The arteriosclerosis obliterans patient treated with Zilver PTX for superficial femoral artery
2.The patients whose drug-eluting stent is implanted in the site that can be observed by endoscopy
Key exclusion criteria
1. Pregnant and lactating women
2. Warfarin user
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinke Toshiro |
Organization
Kobe University Graduate School of Medicine.
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN
TEL
078-382-5846
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinke Toshiro |
Organization
Kobe University Graduate School of Medicine.
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN
TEL
078-382-5846
Homepage URL
sinke@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine.
Division of Cardiovascular Medicine, Department of Internal Medicine.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO Company
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
| 2015 | Year | 08 | 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
| 2013 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | 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
Angioscopic findings
Management information
Registered date
| 2015 | Year | 07 | Month | 14 | Day |
Last modified on
| 2015 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021134
