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

Acronym

CENTURY II Trial

Scientific Title

CLINICAL EVALUATION OF NEW TERUMO DRUG ELUTING CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH CORONARY ARTERY DISEASE

Scientific Title:Acronym

CENTURY II Trial

Region

Japan	Asia(except Japan)	Europe

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, by proving non-inferiority to the Xience everolimus eluting stent, with respect to the freedom from TLF 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 Target Lesion Failure (TLF), a device oriented composite endpoint (cardiac death and MI not clearly attributable to a non-target vessel, and clinically driven Target Lesion Revascularisation (TLR)) at 9 months post stent implantation for COHORT A and COHORT C

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Implantation of TCD-10023

Interventions/Control_2

Implantation of Xience

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patient is  18 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. The target lesion(s) or target vessel(s) meet(s) all the following criteria:
a) The stenosis of target lesion(s) is ≥ 50% by visual estimation;
b) The target lesion can be covered by a maximum of two stents, except in bailout situation;
c) The target vessel reference diameter must be suitable by visual estimation for treatment with stents between 2.5 and 4.0 mm;
6. 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;
7. The patient is willing and able to comply with all specified follow-up evaluations;
8. Patient is affiliated to social security or equivalent system (only for France).

Key exclusion criteria

1.not a suitable candidate for DAPT, 2.known allergy to sirolimus, everolimus, 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.The patient has 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. n 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.under judicial protection (only for France)
Additional Exclusion criteria for COHORT A
1.not less than 20 years old (in Japan only), 2.Target vessel reference D requires stent of 4.0 mm D (in Japan only), 3.AMI within 48 hours before baseline procedure, 4.Previous PCI with stenting (within 30 days), 5.Previous stenting within the TL, 6.refuse a blood transfusion, 7.a widespread peripheral vascular disease that would interfere with vascular access, 8.The TL(s) has any of the following characteristics, a)Bifurcation lesion that need stenting of main and side branch, b) Ostial lesion, c) TL is located in or supplied by an arterial or venous bypass graft, d) TL would require vessel preparation other than balloon-predilatation, 9.TL is located in left main trunk, 10.More than one lesion per vessel and more than 2 vessels disease

Target sample size

1120

Name of lead principal investigator

1st name
Middle name
Last name	Dr. William Wijns, Dr Shiegeru Saito

Organization

Onze Lieve Vrouwziekenhuis
Shonan Kamakura General Hospital

Division name

Cardiology

Zip code

Address

Moorselbaan 164, 9300 Aalst, Belgium, 1202-1 Yamasaki, Kamakura-city, Kanagawa 247-8533, JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name	Kazuhisa SENSHU

Organization

Terumo Europe N.V.

Division name

European Medical and Clinical division

Zip code

Address

Interleuvenlaan 40,3001, Leuven, Belgium

TEL

+3216381524

Homepage URL

Email

TERUMOCENTURY2@terumo-europe.com

Institute

Terumo Europe N.V.

Institute

Department

Personal name

Organization

Terumo Europe N.V.

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

2012

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

http://eurheartj.oxfordjournals.org/content/early/2014/05/19/eurheartj.ehu210.abstract

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

2011

Year

12

Month

05

Day

Date of IRB

Anticipated trial start date

2012

Year

02

Month

01

Day

Last follow-up date

2018

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

12

Month

24

Day

Last modified on

2016

Year

06

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008202