UMIN-CTR Clinical Trial

Public title

Evaluating the usability and safety of 4Fr straight shaped guiding catheter `KIWAMI` (Terumo Corporation) by using mother-and-child technique with severe lesions.

Acronym

Evaluation of PCI devices' delivery success rate by using KIWAMI

Scientific Title

Evaluating the usability and safety of 4Fr straight shaped guiding catheter `KIWAMI` (Terumo Corporation) by using mother-and-child technique with severe lesions.

Scientific Title:Acronym

Evaluation of PCI devices' delivery success rate by using KIWAMI

Region

Japan

Condition

Ischemic heart disease (IHD)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the usability and safety of KIWAMI with 30 consecutive clinical cases which all have difficulties in delivering the PCI devices to the target lesion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Delivery success rate of PCI devices to the target lesion.

Key secondary outcomes

1. The incidence of ST elevated myocardial infarction in case of successful delivery of PCI devices.
2. The incidence of non-ST elevated myocardial infarction after successful deliver of PCI devices.
3. ST changes after successful deliver of PCI devices.
4. Changes at subjective and objective symptoms.
5. Presence of adverse events

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with ischemic heart disease with all of the following criteria will be eligible for enrollment:
1. Are age > 20 years.

2. Have angiographic findings of ischemic heart disease and are eligible to receiving elective PCI treatment.

3. Have consented to participate and have signed the patient informed consent form which is approved by IRB to submit to the implementing institute.

4. Are applicable to coronary artery bypass grafting (CABG).

Key exclusion criteria

1.Exhibit angiographic evidence of severe thrombus in the target site and determined by the physician that the enrollment is not eligible.

2.Have symptoms of unstable angina pectoris and determined by the physician that the enrollment is not eligible.

3.Have symptoms of myocardial infarction and determined by the physician that the enrollment is in not eligible.

4.Have a contraindication to antiplatelet or anticoagulation therapy.

5.Have allergies to contrast media, metal, or other medical agents / materials.

6.Have small reference vessel diameter at the lesion which is suspected as inducing ischemic
heart disease by using KIWAMI.

7.Others: Any cases when the physician determined that the enrollment is not eligible.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Masashi Iwabuchi

Organization

kokura memorial hospital

Division name

cardiology

Zip code

Address

1-1 kifunemachi, kokura-kitaku, kitakyusyu, Fukuoka, Japan

TEL

093-921-2231

Email

Name of contact person

1st name
Middle name
Last name

Organization

kokura memorial hospital

Division name

cardiology

Zip code

Address

TEL

Homepage URL

Email

kmhptca@kokura-heart.com

Institute

Kyusyu KIWAMI regstry group

Institute

Department

Personal name

Organization

none

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

Date of disclosure of the study information

2009

Year

10

Month

27

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

2009

Year

09

Month

29

Day

Date of IRB

Anticipated trial start date

2009

Year

10

Month

01

Day

Last follow-up date

2010

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a sampling of evaluating the usability of KIWAMI with consecutive 30 clinical cases which all have difficulties in delivering the PCI devices to the target lesion.

Registered date

2009

Year

10

Month

27

Day

Last modified on

2017

Year

05

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003259