UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Neo-intimal Coverage after Coronary Stent Implantation by High-Resolution Angioscopic Catheter
Acronym	Evaluation of Coronary Artery after Stent Implantation
Scientific Title	Evaluation of Neo-intimal Coverage after Coronary Stent Implantation by High-Resolution Angioscopic Catheter
Scientific Title:Acronym	Evaluation of Coronary Artery after Stent Implantation
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, intravascular observation with the latest angioscope will enable us to grasp the status of stent coverage, in-stent neoatherosclerosis and in-stent thrombosis.
Basic objectives2	Others
Basic objectives -Others	These results are expected to provide insight as to DES with which polymer will be needed.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Stent coverage at 9+/-3 months after stent placement as observed by angioscopy
Key secondary outcomes	- In-stent neoatherosclerosis and in-stent thrombosis at 9+/-3 months after stent placement as observed by angioscopy - Follow-up catheterization findings at 9 +/- 3 months after stent placement as observed by angioscopy - In-stent neoatherosclerosis, stent coverage and in-stent thrombosis at 3 +/- 1 months after stent placement as observed by angioscopy - Follow-up catheterization findings at 3 +/- 1 months after stent placement as observed by angioscopy - Other exploratory analyses by means of the data acquired through this study including clinical phenomena

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	i) Patients aged 20 years or older at the time of informed consent; ii) Cases of significant stenotic lesions in the coronary artery with a vessel diameter of 2.5 mm to 3.5 mm, which are visually confirmed by coronary angiography; iii) Cases where the data on coronary angiography and IVUS before and after stent placement are properly recorded; and iv) With regard to the cases already underwent angioscopy at 9 +/- 3 months after stent placement, cases where the stent placement site was observed with the blood fully removed over the entire length.
Key exclusion criteria	i) Cases where the treatment site to be observed is completely obstructed, highly calcified or in the left main trunk; ii) Cases with another stent placed within 10 mm of the stent placement site subject to observation; iii) Patients with cardiogenic shock or significantly decreased cardiac function (EF: 30% or less); iv) Patients undergoing maintenance dialysis; v) Patients who are participating or planning to participate in other clinical trials or in clinical studies that require intervention before this study's follow-up catheterization at 9 +/- 3 months after stent placement finishes; vi) With regard to the cases before follow-up catheterization at 9 +/- 3 months after stent placement, cases in which follow-up catheterization at 9 +/- 3 months seems to be difficult to undergo.; and vii) Patients who are pregnant or breast-feeding.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shinsuke Middle name Last name Nanto
Organization	Nishinomiya Municipal Central Hospital
Division name	Department of Cardiology
Zip code	663-8014
Address	8-24, Hayashida-cho, Nishinomiya, Hyogo
TEL	0798-64-1515
Email	snanto@bca.bai.ne.jp

Public contact
Name of contact person	1st name Keita Middle name Last name Okayama
Organization	Osaka University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	565-0871
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3638
Homepage URL
Email	okayama@cardiology.med.osaka-u.ac.jp

Sponsor
Institute	Department of Cardiology, Nishinomiya Municipal Central Hospital
Institute
Department

Funding Source
Organization	Boston Scientific Japan Ovalis
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	Osaka University Hospital, Clinical Research Center
Address	post code 565-0871 2-15, Yamadaoka, Suita, Osaka
Tel	06-6879-5111
Email	rinri@hp-crc.med.osaka-u.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 01 Month 28 Day

Related information
URL releasing protocol	to be prepared
Publication of results	Unpublished

Result
URL related to results and publications	to be prepared
Number of participants that the trial has enrolled	61
Results	A strong relationship was observed between NIC grade and in-stent thrombus in all stents (p=0.0011), and between the heterogeneity value and stent thrombus (p=0.012). There was no statistical difference in NIC grade between BP CoPt-EES vs. DP CoCr-EES(p=0.17) and neither in the heterogeneity value of neointima (p=0.49). The ratio of stent thrombus did not reach statistical difference(p=0.23).
Results date posted	2022 Year 01 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Of patients who underwent Synergy implantation with IVUS or PCI with XIENCE in or after April, 2016, and then were or are going to be followed up within 12 months after the procedure by observation with coronary angiography, IVUS and angioscope, those who will have completed these tests by March, 2020 will be enrolled.
Participant flow	same as above
Adverse events	none
Outcome measures	Stent coverage at 6 to 12 months after stent placement as observed by angioscopy
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 12 Month 03 Day
Date of IRB	2018 Year 12 Month 03 Day
Anticipated trial start date	2018 Year 12 Month 04 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study results will be published in academic meetings, scientific journals, etc. after making the subjects unidentifiable. When publishing the primary results (results of the endpoints defined in the protocol) obtained from this clinical study at academic meetings and as a paper, the author, coauthors and procedure will be determined by the Steering Committee. Sub-analyses of other endpoints not specified in the protocol of this study will be published by the participating medical institutions after gaining approval of the Steering Committee.

Management information
Registered date	2019 Year 01 Month 27 Day
Last modified on	2022 Year 08 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040648