UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006940
Receipt No. R000008202
Scientific Title CLINICAL EVALUATION OF NEW TERUMO DRUG ELUTING CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH CORONARY ARTERY DISEASE
Date of disclosure of the study information 2012/02/01
Last modified on 2016/06/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
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

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

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
Last 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

Public contact
1st 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

Sponsor
Institute Terumo Europe N.V.
Institute
Department

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
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

Progress
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
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/ctr_e/ctr_view.cgi?recptno=R000008202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.