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 UMIN000012928
Receipt No. R000015096
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
Date of disclosure of the study information 2014/03/17
Last modified on 2017/01/25

* 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 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
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 (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

Assessment
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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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 -@-

Public contact
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

Sponsor
Institute Terumo Corporation
Institute
Department

Funding Source
Organization Terumo Corporation
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
2014 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
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

Progress
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
Other related information

Management information
Registered date
2014 Year 01 Month 23 Day
Last modified on
2017 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015096

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.