UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluating the usability and safety of 4Fr straight shaped guiding catheter `KIWAMI` (Terumo Corporation) by using mother-and-child technique with severe lesions.
Title of the study (Brief title)	Evaluation of PCI devices' delivery success rate by using KIWAMI
Region	Japan

Condition
Condition	Ischemic heart disease (IHD)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Masashi Iwabuchi
Organization	kokura memorial hospital
Division name	cardiology
Address	1-1 kifunemachi, kokura-kitaku, kitakyusyu, Fukuoka, Japan
TEL	093-921-2231
Email

Public contact
Name of contact person
Organization	kokura memorial hospital
Division name	cardiology
Address
TEL
Homepage URL
Email	kmhptca@kokura-heart.com

Sponsor
Institute	Kyusyu KIWAMI regstry group
Institute
Department

Funding Source
Organization	none
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

Other administrative information
Date of disclosure of the study information	2009 Year 10 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 29 Day
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

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Publication of results	Unpublished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

Management information
Registered date	2009 Year 10 Month 27 Day
Last modified on	2017 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003259