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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002679
Receipt No. R000003259
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.
Date of disclosure of the study information 2009/10/27
Last modified on 2017/05/12

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Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
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/ctr_e/ctr_view.cgi?recptno=R000003259

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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