UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032068 |
|---|---|
| Receipt number | 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 19:57:26 |
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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
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
r-arai@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036475
