UMIN-CTR Clinical Trial

Public title

MECHANISM for pro-healing advantage of ULTIMASTER sirolimus-eluting stent assessed by early and late optical frequency domain imaging in Elective case

Acronym

MECHANISM- ULTIMASTER-Elective

Scientific Title

MECHANISM for pro-healing advantage of ULTIMASTER sirolimus-eluting stent assessed by early and late optical frequency domain imaging in Elective case

Scientific Title:Acronym

MECHANISM- ULTIMASTER-Elective

Region

Japan

Condition

Coronary Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To treat patients with stable coronary artery disease, elective PCI will be performed with the use of an ULTIMASTER sirolimus-eluting stent, which is the current standard DES. Vascular responses at the site of stent placement will be evaluated by OFDI at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OFDI findings and the time course of platelet aggregation and between OFDI findings and the occurrence of major cardio-cerebrovascular events will also be elucidated.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Rate of stent-strut coverage determined by OFDI at 3 months after stent placement (To observe temporal course from the early stage, the rate of stent-strut coverage in the 1-month arm will also be evaluated in a complementary manner, separately from the 3-month arm.)

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

85

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated;
2) Patients aged 20 to less than 85 years at the time of informed consent
3) Patients who have provided informed consent written by themselves
4) Patients who are able to undergo OFDI examinations of the site of stent placement at 1 or 3 months and at 12 months

Key exclusion criteria

1) If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.)
2) Patients with acute myocardial infarction (AMI)
3) Patients in a state of shock
4) Patients with cardiac failure
5) Patients having a culprit lesion in the left main coronary artery trunk
6) Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate
7) Patients having an in-stent restenosis lesion as the culprit lesion
8) Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit
9) Patients on hemodialysis
10) Cancer patients with a life expectancy of less than 2 years
11) Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months
12) Pregnant women or women expected to become pregnant
13) Patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Toshiro Shinke

Organization

Kobe University Graduate School of Medicine

Division name

Devision of Cardiovascular Medicine

Zip code

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo

TEL

078-881-1212

Email

shinke@med.kobe-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kanako Omiya

Organization

The Academic Research Group for Exploring Undiscovered Mechanisms of Cardiovascular Diseases

Division name

Department of cardiovascular medicine

Zip code

Address

19-1 Uchimaru, Morioka, Iwate

TEL

019-651-5111

Homepage URL

Email

komiya@iwate-med.ac.jp

Institute

Department of Internal Medicine, Kobe University Graduate School of Medicine

Institute

Department

Personal name

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

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

Date of disclosure of the study information

2016

Year

03

Month

16

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

Enrolling by invitation

Date of protocol fixation

2016

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

03

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Vascular responses at the site of ULTIMASTER silolomus-eluting stent placement will be evaluated by OFDI at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OFDI findings and the time course of platelet aggregation and between OFDI findings and the occurrence of major cardio-cerebrovascular events will also be elucidated.

Registered date

2016

Year

02

Month

21

Day

Last modified on

2016

Year

10

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023994