UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	MUlti-center Registry exAmining synergy everoliMus bioAbsorbable polymer Stent in coronary intervention of complex Arterial lesion subsets registry
Title of the study (Brief title)	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	Kenya Nasu, Yuji Oikawa
Organization	Toyohashi Heart Center, The Cardiovascular Institute
Division name	Cardiology
Address	21-1 O-yama cho, Toyohashi, Aichi, 4418530, Japan
TEL	+81532373377
Email	yuyatomoya@gmail.com

Public contact
Name of contact person	Kenya Nasu
Organization	Toyohashi Heart Center
Division name	Cardiology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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