Unique ID issued by UMIN | UMIN000006575 |
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Receipt number | 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 08:13:40 |
CLINICAL EVALUATION OF NEW TERUMO DRUG ELUTING CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH CORONARY ARTERY DISEASE
CENTURY Study
CLINICAL EVALUATION OF NEW TERUMO DRUG ELUTING CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH CORONARY ARTERY DISEASE
CENTURY Study
Europe |
Ischemic heart disease
Medicine in general | Cardiology |
Others
NO
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.
Safety,Efficacy
Confirmatory
Phase II
Late Loss at 6 months
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
Implantation of TCD-10023
18 | years-old | <= |
Not applicable |
Male and Female
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.
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
100
1st name | |
Middle name | |
Last name | Dr. William Wijns |
Onze Lieve Vrouwziekenhuis
Cardiology
Moorselbaan 164, 9300 Aalst, Belgium
1st name | |
Middle name | |
Last name |
Terumo Europe N.V.
European Medical and Clinical division
EMCDCENTURY@terumo-europe.com
Terumo Europe N.V.
Terumo Europe N.V.
Profit organization
NO
2011 | Year | 10 | Month | 18 | Day |
Partially published
http://www.pcronline.com/eurointervention/AbstractsEuroPCR2014/MA053/
Main results already published
2011 | Year | 06 | Month | 08 | Day |
2011 | Year | 10 | Month | 01 | Day |
2011 | Year | 10 | Month | 18 | Day |
2015 | Year | 10 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007782
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