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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002573
Receipt No. R000003134
Scientific Title Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion
Date of disclosure of the study information 2009/10/01
Last modified on 2015/05/11

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Basic information
Public title Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion
Acronym G-FORCE
Scientific Title Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion
Scientific Title:Acronym G-FORCE
Region
Japan

Condition
Condition Patients undergoing Percutaneous Coronary Intervention (PCI) for chronic total occlusion (CTO)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Under the circumstances that appropriate first-choice guidewires for percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) have yet to be established, the objective of this study is to determine appropriate first-choice guidewires.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Lesion penetration rate of a first-choice guidewire
Key secondary outcomes Successful PCI rate
Definition of successful PCI: The target lesion is successfully dilated without any major cardiovascular events.
Types of guidewires successfully passing through the lesion
Usage rate and success rate of the retrograde approach
Usage rate and success rate of the parallel wire technique
Usage rate and success rate of IVUS assistance
Usage rate and success rate of coronary CT
Total death
Cardiac death
Myocardial infarction (MI) (Q-wave/non-Q-wave)
Emergency surgeries (CABG/other)
Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures)
Stroke
Guidewire-induced perforation
Cardiac tamponade
Hemorrhagic complications
Puncture site complications
Sizes and types of guiding catheters
Approach sites
Total number of guidewires used
Total number of guiding catheters used
Total number of CTO treated cases during the enrollment period

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Primary guidewire is normal size (distal tip = 0.014 inch)
Interventions/Control_2 Primary guidewire is slender size (dista tip equal to or less than 0.010inch)
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 a PCI-treatable CTO lesion in a main vessel of the coronary arteries
Patients with a de novo CTO lesion
Patients undergoing an elective PCI procedure
Patients who provide informed consent
Key exclusion criteria Patients for whom PCI is not indicated
Patients with the same CTO previously treated with PCI without success
Patients with restenosis or in-stent restenosis
Patients with a venous or arterial graft
Patients under 21 years old
Women of child-bearing potential
Patients who do not provide informed consent
Target sample size 290

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Ikari
Organization Tokai University School of Medicine
Division name Cardiology
Zip code
Address 143, Shimokasuya, Isehara, Kanagawa, Japan
TEL 0463-63-1121
Email ikari@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chie Kato
Organization Tokai University School of Medicine
Division name Cardiology
Zip code
Address 143, Shimokasuya, Isehara, Kanagawa, Japan
TEL 0463-63-1121
Homepage URL
Email tokai-rinsho@ml.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

Funding Source
Organization Kaneka Medics
Terumo
Japan Lifeline
Asahi Intech
Abbott Vascular
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00987610
Org. issuing International ID_1 ClinicalTrials.gov
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 01 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 19 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 07 Month 15 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 01 Day
Last modified on
2015 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003134

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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