UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	CLINICAL EVALUATION OF NEW TERUMO DRUG ELUTING CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH CORONARY ARTERY DISEASE
Title of the study (Brief title)	CENTURY II Trial
Region	Japan Asia(except Japan) Europe

Condition
Condition	Ischemic heart disease
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
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

Intervention
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patient is &#61619; 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 &#8805; 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

Research contact person
Name of lead principal investigator	Dr. William Wijns, Dr Shiegeru Saito
Organization	Onze Lieve Vrouwziekenhuis Shonan Kamakura General Hospital
Division name	Cardiology
Address	Moorselbaan 164, 9300 Aalst, Belgium, 1202-1 Yamasaki, Kamakura-city, Kanagawa 247-8533, JAPAN
TEL
Email

Public contact
Name of contact person	Kazuhisa SENSHU
Organization	Terumo Europe N.V.
Division name	European Medical and Clinical division
Address	Interleuvenlaan 40,3001, Leuven, Belgium
TEL	+3216381524
Homepage URL
Email	TERUMOCENTURY2@terumo-europe.com

Sponsor
Institute	Terumo Europe N.V.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Terumo Europe N.V.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 02 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://eurheartj.oxfordjournals.org/content/early/2014/05/19/eurheartj.ehu210.abstract
Results
Other related information

Management information
Registered date	2011 Year 12 Month 24 Day
Last modified on	2016 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008202