UMIN-CTR Clinical Trial

Public title

Clinical trial to evaluate efficacy and safety of KCS03 stent in a native coronary lesion

Acronym

KCS03-1

Scientific Title

Clinical trial to evaluate efficacy and safety of KCS03 stent in a native coronary lesion

Scientific Title:Acronym

KCS03-1

Region

Japan

Condition

Stable angina, unstable angina and non-ST elevated myocardial infarction with de novo or restenotic coronary lesions

Classification by specialty

Cardiology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To certify efficacy and safety of KCS03 in Japan

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

TVF at 6 months

Key secondary outcomes

Technical success, procedural success, degree of stenosis immediately after the procedure, degree of stenosis (in-stent or in-segment) at 6 months, restenosis at 6 months, TLR at 6 months, TVR at 6 months, adverse events, stent thrombosis at 6 months, MACE at 6 months and length of hospital stay after the procedure

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

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

(1)Age 20 or over
(2)Eligible for PCI
(3)Evidence of stable angina or ischemic unstable angina or ischemic non-ST elevated myocardial infarction or silent ischemia
(4)Eligible for CABG
(5)Target lesion is located in a single native coronary artery.
(6)Target lesion length is less than 28mm.
(7)Reference vessel diameter is more than 3.0mm and less than 4.0mm.
(8)Diameter stenosis of target lesion is more than 50%.

Key exclusion criteria

(1)Cardiogenic shock
(2)After cardiopulmonary resuscitation
(3)LVEF is less than 25%
(4)Previous every DES implantation or scheduled DES implantation within 6 months against target vessel or side branches
(5)Every PCI procedures within prior 30 days against coronary arteries
(6)ST elevated myocardial infarction
(7)Cerebral stroke or TIA within prior 30 days
(8)Acute or chronic renal insufficiency (creatinine is more than 2.0mg/dL.)
(9)Active gastric ulcer or active gastrointestinal bleeding
(10)Life expectation is less than 12 months.
(11)Non-target lesion requiring treatment is located in the target vessel or side branches of the target vessel.
(12)Any lesions are located in LMT.
(13)Target lesion is located in a bypass graft.
(14)Target lesion is located in the ostium of the vessel.
(15)Moderate or severe calcification is observed in target lesion or proximal side of target lesion.

Target sample size

115

Name of lead principal investigator

1st name
Middle name
Last name	Toshiya Muramatsu, Yuji Ikari

Organization

Saiseikai Yokohamashi Tobu Hospital, Tokai University Hospital

Division name

Cardiovascular Internal Medicine, Cardiovascular Internal Medicine

Zip code

Address

3-6-1, Shimo-Sueyoshi, Tsurumi-ku, Yokohama-shi, Kanagawa 230-8765, 143 Shimokasuya, Isehara-shi, Kanagawa 259-1193

TEL

050-3133-7848

Email

Takayuki.Ohno@kaneka.co.jp

Name of contact person

1st name
Middle name
Last name	Takayuki Ohno

Organization

Kaneka Corporation

Division name

Medical devices division

Zip code

Address

2-3-18, Nakanoshima, Kita-ku, Osaka-shi, Osaka

TEL

050-3133-7848

Homepage URL

Email

Takayuki.Ohno@kaneka.co.jp

Institute

Kaneka Corporation

Institute

Department

Personal name

Organization

Kaneka 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

2013

Year

04

Month

08

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

Completed

Date of protocol fixation

2012

Year

07

Month

10

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

04

Day

Last modified on

2015

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012187