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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008651
Receipt No. 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

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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
Email

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
Email yuyatomoya@gmail.com

Sponsor
Institute The PCI Guideline Research Society
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010149

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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