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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018314
Receipt No. 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

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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
Email 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
Email sinke@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine.
Division of Cardiovascular Medicine, Department of Internal Medicine.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021134

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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