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 UMIN000006575
Receipt No. R000007782
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 2011/10/18
Last modified on 2015/10/19

* 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 Study
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 Study
Region
Europe

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

Objectives
Narrative objectives1 To evaluate the safety and effectiveness of TCD-10023 drug eluting stent (DES) for the treatment of up to two de novo lesions or restenotic post-PTCA (non-stented) lesions located in up to two (maximum one lesion per vessel) epicardial native coronary arteries suitable for treatment with stents in diameter from 2.5 to 4.0 mm.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Late Loss at 6 months
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
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) and acceptable candidate for coronary artery bypass grafting (CABG).
3) Clinical evidence of ischemic heart disease and/or a positive functional study, stable angina pectoris (Canadian Cardiovascular Society Classification (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or silent ischemia.
4) The target lesion(s) or target vessel(s) meet(s) all the following criteria;
a) The target lesion is a single de novo lesion or restenotic post-PTCA (non-stented) lesion in one or two native coronary artery.
b) The stenosis of target lesion(s) is > 50% and < 100% (by visual estimation).
c) The target lesion length must be < 25 mm.
d) The target reference vessel diameter must be (by visual estimation) suitable for treatment with stents between 2.5 and 4.0 mm.
5) Patient has been informed of the nature of the study, understands the study requirements and 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.

Key exclusion criteria 1) Most recent LVEF is < 25%
2) Known allergies to aspirin, Clopidogrel bisulfate, Prasugrel or Ticlopidine, heparin, cobalt, chromium, nickel, or contrast agent or Sirolimus
3) A platelet count is < 100K or > 700K
4) WBC count is < 3.5K
5) Evidence of an ST-segment elevation acute MI or Non-ST segment elevation MI with positive Troponin within 72h of the intended treatment
6) Previous PCI
7) Presence of any other significant lesion of > 50% stenosis anywhere within the target vessel (TV)
8) Significant lesions in any non-TV that will require interventional treatment, within 30 days post-procedure
9) Planned future interventional procedure in the TV is not allowed
10) The target lesions requires treatment with a device other than PTCA balloon prior to stent placement
11) Previous stenting anywhere within the TVs
12) TV has evidence of thrombus
13) Excessive tortuousity of the TV proximal to the target lesion (TL)
14) Either of the following characteristics in the TLs
a) Ostial TL or bifurcation lesion
b) TL involves a side branch
c) TL has excessive tortuousity
d) Moderate to severely calcified lesion which can not be successfully predilated
e) TL is located in or supplied by an arterial or venous bypass graft
f) Significant stenosis proximal or distal to the TL
g) A complete occlusion
15) TL is located in left main trunk.
16) Stroke or transient ischemic attack within the prior 180d
17) Active peptic ulcer or upper GI bleeding within the prior 180d
18) The PT (patient) has bleeding hemorrhagic diathesis or coagulopathy.
19) The PT will refuse a blood transfusion
20) The PT has a widespread peripheral vascular disease
21) Acute or chronic renal dysfunction
22) The PT requires multiple stent implantations for a tandem lesion
23) Life expectancy <1Y
24) PT is currently participating in other clinical studies
25) In the investigators opinion PT has co-morbid conditions that could limit the PTs ability to participate in the study
26) PT in cardiogenic shock
27) Female of child-bearing potential
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dr. William Wijns
Organization Onze Lieve Vrouwziekenhuis
Division name Cardiology
Zip code
Address Moorselbaan 164, 9300 Aalst, Belgium
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Terumo Europe N.V.
Division name European Medical and Clinical division
Zip code
Address
TEL
Homepage URL
Email EMCDCENTURY@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
2011 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.pcronline.com/eurointervention/AbstractsEuroPCR2014/MA053/
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 06 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 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
2011 Year 10 Month 18 Day
Last modified on
2015 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007782

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.