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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027378
Receipt No. R000031372
Scientific Title MUlti-center Registry exAmining synergy everoliMus bioAbsorbable polymer Stent in coronary intervention of complex Arterial lesion subsets registry
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/17

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Basic information
Public title MUlti-center Registry exAmining synergy everoliMus bioAbsorbable polymer Stent in coronary intervention of complex Arterial lesion subsets registry
Acronym MURAMASA registry
Scientific Title MUlti-center Registry exAmining synergy everoliMus bioAbsorbable polymer Stent in coronary intervention of complex Arterial lesion subsets registry
Scientific Title:Acronym MURAMASA 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 everolimus bioabsorbable polymer Stent 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 Bioabsorbable polymer-coated, everolimus-Eluting coronary stent
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 yuyatomoya@gmail.com

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 Treatment of complex coronary lesion research society
Institute
Department

Funding Source
Organization Treatment of complex coronary lesion 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)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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
2017 Year 05 Month 17 Day
Last modified on
2017 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031372

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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