UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002573 |
|---|---|
| Receipt number | 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 13:07:47 |
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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
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
tokai-rinsho@ml.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003134
