UMIN-CTR Clinical Trial

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

Complex coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Treatment of complex coronary lesion research society

Institute

Department

Personal name

Organization

Treatment of complex coronary lesion research society

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2017

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

05

Month

17

Day

Last modified on

2017

Year

05

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031372