Unique ID issued by UMIN | UMIN000008076 |
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Receipt number | R000009511 |
Scientific Title | Clinical Performance of the Endeavor Zotarolimus-Eluting Stent in Real-world Japanese Patients: A Prospective Multicenter Registry |
Date of disclosure of the study information | 2012/06/04 |
Last modified on | 2013/12/06 13:53:36 |
Clinical Performance of the Endeavor Zotarolimus-Eluting Stent in Real-world Japanese Patients: A Prospective Multicenter Registry
E-KANSAI Registry
Clinical Performance of the Endeavor Zotarolimus-Eluting Stent in Real-world Japanese Patients: A Prospective Multicenter Registry
E-KANSAI Registry
Japan |
Ischemic Heart Disease/Coronary Artery Disease
Cardiology |
Others
NO
This study aims to evaluate the long-term efficacy and safety of the Endeavor stent system in the current clinical setting. Results from the study will be compared with those from the E-Five study, which is a large-scale registry study conducted in South America, Europe, Asia, and Oceania to reflect the actual clinical use of the device, for the purpose of comparing clinical data of the Endeavor stent system in Japan and overseas countries.
Safety,Efficacy
Confirmatory
Phase IV
Incidence of major adverse cardiac events (MACE; defined as all-cause death, myocardial infarction, coronary artery bypass grafting, and target lesion revascularization [TLR]) at 12 months post-procedure.
Incidence of subacute stent thrombosis between 0 and 30 days post-procedure, and incidence of late-onset stent thrombosis between 31 and 360 days post-procedure.
Observational
18 | years-old | <= |
Not applicable |
Male and Female
1. Age of 18 years or older.
2. Clinical symptoms of ischemic heart
disease, OR ischemia confirmed by
cardiac function tests.
3. Patients eligible for percutaneous
transluminal coronary angioplasty
(PTCA) and stent implant procedure.
4. Pre-procedure consent to the details
and conditions of the study after pre-
procedure explanation of the study,
in principle. Post-procedure patient
enrollment requires prior approval of
the joint ethical committee for the
method of post-procedure enrollment.
1. Women known to be pregant or
lactating mothers.
2. Known hypersensitivity or allergy to
drugs including aspirin, heparin,
clopidogrel, ticlopidine, and ABT-
578; rapamycin, tacrolimus,
sirolimus, or their analogues, or
other analogues/derivatives; or
cobalt, chrome, nickel, molybdenum,
or contrast media.
3. Life expectancy estimated to be less
than 12 months.
4. Acute myocardial infarction (AMI)
accompanied by cardiogenic shock.
5. Preexisting stents (drug-eluting
stents [DES] or bare metal stents
[BMS]) in the target vessel (stents
in a branch of the target vessel do
not preclude enrollment).
6. Patients known to have difficulty in
continuing dual antiplatelet therapy
(DAPT) because of a plan of other
surgery after stenting.
1000
1st name | |
Middle name | |
Last name | Satoru Otsuji |
Higashi Takarazuka Satoh Hospital
Department of Cardiology
2-1 Nagao-cho,Takarazuka City, Hyogo, Japan
+81.797.88.2200
aeei_trial@aeeijapan.org
1st name | |
Middle name | |
Last name | Satoru Otsuji |
Higashi Takarazuka Satoh Hospital
Department of Cardiology
2-1 Nagao-cho,Takarazuka City, Hyogo, Japan
+81.797.88.2200
aeei_trial@aeeijapan.org
Associations for Establishment of Evidence in Interventions
Associations for Establishment of Evidence in Interventions
Other
NO
2012 | Year | 06 | Month | 04 | Day |
Partially published
No longer recruiting
2010 | Year | 02 | Month | 01 | Day |
2010 | Year | 02 | Month | 01 | Day |
2013 | Year | 07 | Month | 01 | Day |
2013 | Year | 08 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
Site visit is not necessarily needed for survival confirmation, which can be done with other means, such as telephone and e-mail. However, if a patient reports any coronary intervention or diagnostic imaging performed after the last follow-up or complains of any ischemic symptoms or other symptoms suggesting ischemia, the patient should be encouraged to visit the site for necessary follow-up assessments.
Clinical follow-up will be conducted to assess clinical endpoints including the incidence of MACE. Site visits will be planned at 30 days, 6 to 8 months, and 12 months post-procedure. Each follow-up can be done via telephone or other means for survival confirmation and will not necessarily require site visit. However, if a subject reports that he or she had any coronary intervention or diagnostic tests and diagnostic imaging, or any ischemia-related symptoms, the subject must visit the site for follow-up assessments.
2012 | Year | 06 | Month | 01 | Day |
2013 | Year | 12 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009511
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