UMIN-CTR Clinical Trial

Public title

Clinical Evaluation of New Terumo drug elUting coRonary stent system in the treatment of patients with coronarY artery disease in Small Vessels in Japanese population

Acronym

CENTURY JSV Trial

Scientific Title

Clinical Evaluation of New Terumo drug elUting coRonary stent system in the treatment of patients with coronarY artery disease in Small Vessels in Japanese population

Scientific Title:Acronym

CENTURY JSV Trial

Region

Japan

Condition

Ischemic heart disease

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To demonstrate the safety and efficacy of the TCD-10023 sirolimus eluting stent (diameter 2.25 mm), by proving superiority to the POBA, with respect to the freedom from MACE at 9 months

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Freedom from Major Adverse Cardiac Events (MACE), a device oriented composite endpoint (cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven Target Lesion Revascularization (TLR)) at 9 months post stent implantation

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Implantation of TCD-10023

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

1. Patient is >=20 years old;
2. Patient is eligible for percutaneous coronary intervention (PCI) using DES;
3. Patient is acceptable candidate for CABG;
4. Patient has clinical evidence of ischemic heart disease and/or a positive functional study. Stable or unstable angina pectoris, or documented silent ischemia;
5. Patient has been informed of the nature of the study, understands the study requirements, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site;
6. The patient is willing and able to comply with all specified follow-up evaluations;
7.The target lesion or target vessel meet all the following criteria:
a) The significant stenosis of target lesion needs to be treated;
b) The target lesion can be covered by one stent, except in bailout situation;
c) The target vessel reference diameter must be suitable by visual estimation for treatment with 2.25 mm stents;

Key exclusion criteria

1.Not a suitable candidate for DAPT,
2.Known allergy to Limus family drugs, cobalt, chromium, nickel, or contrast agent,
3.Most recent LVEF of the patient is not more than 25%,
4.PLT count is less than 100K cells/mm3 or more than 700K cells/mm3,
5.WBC count is less than 3,500 cells/mm3,
6.Cerebral hemorrhage within 180 days prior to the baseline procedure,
7.Active peptic ulcer or upper GI bleeding within 180 days prior to the baseline procedure,
8.Bleeding diathesis or coagulopathy,
9.Any planned future PCI,
10.Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints,
11. In the investigator's opinion, patient has (a) co-morbid conditions(s) that could limit patients's abilibility to participate in the study, compliance with FU requiements or impact the scientific integrity of the study,
12. In cardiogenic shock,
13.Life expectancy less than 1 year,
14. Renal failure requiring dialysis,
15. Female of child-bearing potential,
16.AMI within 48 hours before baseline procedure,
17.Previous PCI with stenting (within 30 days),
18.Previous stenting within the target lesion,
19.Will refuse a blood transfusion,
20.A widespread peripheral vascular disease that would interfere with vascular access,
21.The target lesion and non-target lesion(s) has any of the following characteristics,
a)Bifurcation lesion that need stenting of main and side branch,
b)Ostial lesion involving the origin of the coronary artery within the first 3 mm,
c) Located in or supplied by an arterial or venous bypass graft,
d) Require vessel preparation other than balloon-predilatation,
e) Left main trunk,
f)Chronic total occlusion,
22. There are three or more non-target lesions other than one target lesion.
23.A non-target lesion is located within 15 mm visually from a target lesion.
24. The non-target lesion that need more than 1 stent.

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Dr. Shigeru Saito

Organization

Shonan Kamakura General Hospital

Division name

Cardiology

Zip code

Address

1370-1 Okamoto, Kamakura, kanagawa, Japan

TEL

-

Email

-@-

Name of contact person

1st name
Middle name
Last name	Terumo Corporation

Organization

Terumo Corporation

Division name

Clinical Development Depertment

Zip code

Address

1500 Inokuchi, Nakaimachi, Ashigarakami-gun, Kanagawa, Japan

TEL

0465-81-4106

Homepage URL

Email

Kazuhiro_Endou@terumo.co.jp

Institute

Terumo Corporation

Institute

Department

Personal name

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2014

Year

03

Month

17

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Main results already published

Date of protocol fixation

2014

Year

01

Month

16

Day

Date of IRB

Anticipated trial start date

2014

Year

03

Month

24

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

01

Month

23

Day

Last modified on

2017

Year

01

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015096