UMIN-CTR Clinical Trial

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

Coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Cardiology, Nishinomiya Municipal Central Hospital

Institute

Department

Personal name

Organization

Boston Scientific Japan
Ovalis

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

01

Month

28

Day

URL releasing protocol

to be prepared

Publication of results

Unpublished

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

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 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.

Registered date

2019

Year

01

Month

27

Day

Last modified on

2022

Year

08

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040648