UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008651 |
|---|---|
| Receipt number | R000010149 |
| Scientific Title | Study examining the PROMUS Element everolimus-eluting stent in multi-center Coronary Intervention of complex Arterial Lesion Subsets |
| Date of disclosure of the study information | 2012/08/10 |
| Last modified on | 2012/08/08 17:25:08 |
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Basic information
Public title
Study examining the PROMUS Element everolimus-eluting stent in multi-center Coronary Intervention of complex
Arterial Lesion Subsets
Acronym
SPECIALIST registry
Scientific Title
Study examining the PROMUS Element everolimus-eluting stent in multi-center Coronary Intervention of complex
Arterial Lesion Subsets
Scientific Title:Acronym
SPECIALIST registry
Region
| Japan |
Condition
Condition
Complex coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the clinical outcomes with a platinum chromium everolimus-eluting stent (PtCr-EES) in patients with complex coronary artery disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization at 12 month.
Key secondary outcomes
a.Procedural success
b.Target lesion revascularization at 12 month
c.TVR at 12 month
d.MI at 24 month
e.Death at 24 month
f.MACE at 24 month
g.Stent thrombosis (acute, sub-acute, late,and very late) definited by Academic Research Consortium (ARC) at 24 month
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Platinum chromium everolimus-eluting stent (PtCr-EES) (manufactured as PROMUS Element by Boston Scientific)
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
a. Ischemic heart disease including stable angina pectoris and acute coronary syndrome
b. Male or non-pregnant female
c. Key lesion inclusion criteria as follows
(1) Multi-vessel diseases
(2) Long lesion (lesion length >30mm by visual estimation)
(3) Small vessel disease (reference diameter <2.5mm by visual estimation)
(4) Bifurcation lesion
(5) Ostial lesion
(6) Calcified lesion
(7) Protected or non-protected left main trunk disease
(8) Chronic total occlusion
(9) In stent restenosis of bare metal stent or everolimus-eluting stent
Key exclusion criteria
1) Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
2) Serum creatinine level >3.0 mg/dL
3) Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenya Nasu, Yuji Oikawa |
Organization
Toyohashi Heart Center, The Cardiovascular Institute
Division name
Cardiology
Zip code
Address
21-1 O-yama cho, Toyohashi, Aichi, 4418530, Japan
TEL
+81532373377
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenya Nasu |
Organization
Toyohashi Heart Center
Division name
Cardiology
Zip code
Address
21-1 O-yama cho, Toyohashi, Aichi, 4418530, Japan
TEL
+81532373377
Homepage URL
yuyatomoya@gmail.com
Sponsor or person
Institute
The PCI Guideline Research Society
Institute
Department
Personal name
Funding Source
Organization
The PCI Guideline Research Society
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
1) Toyohashi Heart Center (Aichi)
2) The Cardiovascular Institute (Tokyo)
3) Sapporo Cardio Vascular Clinic (Hokkaido)
4) Nayoro City General Hospital (Hokkaido)
5) Southern Tohoku Research Institute for Neuroscience (Fukushima)
6) Gunma Prefectural Cardiovascular Center (Gunma)
7) Matsumoto Kyoritsu Hospital (Nagano)
8) Ota Memorial Hospital (Gunma)
9) Gunma University Hospital (Gunma)
10) Tsukuba Medical Center Hospital (Ibaragi)
11) Ayase Heart Hospital (Tokyo)
12) Tokyo Metropolitan Hiroo Hospital (Tokyo)
13) NTT Medical Center Tokyo (Tokyo)
14) Itabashi Chuo Medical Center (Tokyo)
15) Juntendo University Urayasu Hospital (Tokyo)
16) Tokyo Metropolitan Police Hospital (Tokyo)
17) Hoshi General Hospital (Fukushima)
18) Katsushika Medical Center (Tokyo)
19) Tokyo-Kita Social Insurance Hospital (Tokyo)
20) Tokyo Rinkai Hospital (Tokyo)
21) Yokohama Rosai Hospital (Kanagawa)
22) Yokohama City Minato Red Cross Hospital (Kanagawa)
23) Seirei Mikatahara General Hospital (Shizuoka)
24) TODA CHUO General Hospital (Saitama)
25) Kasukabe Chuo General Hospital (Saitama)
26) SHUWA General Hospital (Saitama)
27) Aichi Medical University Hospital (Aichi)
28) Kakogawa East City Hospital (Hyogo)
29) Daini Okamoto General Hospital (Kyoto)
30) Rinku General Medical Center (Osaka)
31) Hokusetsu General Hospital (Osaka)
32) Kokura Memorial Hospital (Fukuoka)
33) Saiseikai Kumamoto Hospital (Kumamoto)
34) Saiseikai Fukuoka General Hospital (Fukuoka)
35) JA Hokkaido Engaru Kosei General Hospital (Hokkaido)
36) Megumino Hospital (Hokkaido)
37) Kobe University Hospital (Hyogo)
38) Kansai Rosai Hospital (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Preinitiation
Date of protocol fixation
| 2012 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 08 | Day |
Last modified on
| 2012 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010149
