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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032068
Receipt No. R000036475
Scientific Title Assessment of Restenotic Neointimal Tissue after Second- or Third-Generation Drug-Eluting Stent Implantation: Evaluation by Histopathology, Optimal Coherence Tomography, and Intravascular Ultrasound
Date of disclosure of the study information 2018/04/04
Last modified on 2018/04/02

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Basic information
Public title Assessment of Restenotic Neointimal Tissue after Second- or Third-Generation Drug-Eluting Stent Implantation: Evaluation by Histopathology, Optimal Coherence Tomography, and Intravascular Ultrasound
Acronym Assessment of Restenotic Neointimal Tissue after Second- or Third-Generation Drug-Eluting Stent Implantation: Evaluation by Histopathology, Optimal Coherence Tomography, and Intravascular Ultrasound
Scientific Title Assessment of Restenotic Neointimal Tissue after Second- or Third-Generation Drug-Eluting Stent Implantation: Evaluation by Histopathology, Optimal Coherence Tomography, and Intravascular Ultrasound
Scientific Title:Acronym Assessment of Restenotic Neointimal Tissue after Second- or Third-Generation Drug-Eluting Stent Implantation: Evaluation by Histopathology, Optimal Coherence Tomography, and Intravascular Ultrasound
Region
Japan

Condition
Condition Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess restenotic neointimal tissue after second- or third-generation drug-eluting stent implantation by using optical coherence tomography (OCT), intravascular ultrasound (IVUS), and histopathology analysis of tissue obtained by directional coronary atherectomy (DCA)
Basic objectives2 Others
Basic objectives -Others Evaluation of pathological mechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Histopathological findings, optical coherence tomography (OCT) findings, and intravascular ultrasound(IVUS) findings of restenotic neointimal tissue
Key secondary outcomes

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 -Patients who had restenosis after second- or third-generation DES implantation
-Restenotic lesion considered appropriate to be treated by DCA
-Patients considered appropriate to be used OCT for assessment of restenotic neointimal lesion from the patients background
-Patients who have provided written informed consent

Key exclusion criteria Those who were eligible to above criteria can be registered.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Oikawa
Organization The Cardiovascular Institute
Division name Cardiology
Zip code
Address 3-2-19, Nishiazabu Minato-ku, Tokyo, 106-0031, Japan
TEL 03-3408-2151
Email y-oikawa@cvi.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Riku Arai
Organization The Cardiovascular Institute
Division name Cardiology
Zip code
Address 3-2-19, Nishiazabu Minato-ku, Tokyo, 106-0031, Japan
TEL 03-3408-2151
Homepage URL
Email r-arai@cvi.or.jp

Sponsor
Institute The Cardiovascular Institute
Institute
Department

Funding Source
Organization The Cardiovascular Institute
Organization
Division
Category of Funding Organization Self funding
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 心臓血管研究所付属病院(東京都) The Cardiovascular Institute
東海大学医学部内科学系循環器内科(神奈川県) Department of cardiology, Tokai university hospital

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 04 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
2018 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients are recruiting

Management information
Registered date
2018 Year 04 Month 02 Day
Last modified on
2018 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036475

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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