Guidewire for Chronic Total Occlusion
G-FORCE
Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion
1 other identifier
interventional
260
1 country
25
Brief Summary
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. G-FORCE study is a prospective multicenter randomized study between normal (distal tip size 0.014 inch) and slender (distal tip size 0.010 inch or less) guidewires. Primary end point is lesion penetration rate of the first choice guidewire.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2009
Longer than P75 for phase_4
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2009
CompletedFirst Posted
Study publicly available on registry
October 1, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 4, 2015
May 1, 2015
5.2 years
September 29, 2009
May 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lesion penetration rate of a first-choice guidewire
30 days
Secondary Outcomes (3)
Successful PCI rate
30 days
Types of guidewires successfully passing through the lesion
30 days
Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures)
30 days
Study Arms (2)
slender guidewire
ACTIVE COMPARATORPercutaneous coronary intervention (PCI) using guidewires with small distal tip equal to 0.010 inch or less
normal guidewire
ACTIVE COMPARATORPercutaneous coronary intervention (PCI) using guidewires with normal distal tip equal to 0.014 inch
Interventions
PCI for chronic total occlusion is performed using either arm of guidewire
Eligibility Criteria
You may qualify if:
- Chronic total occlusion (CTO) lesion in native coronary artery
- De novo lesion
- Elective procedure
You may not qualify if:
- No indication of PCI
- Prior failed lesion
- Restenotic or in-stent restenotic lesion
- Vein or arterial grafts
- Younger than 20 years old
- Pregnant woman
- Patients who gave no informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tokai Universitylead
- Abbott Medical Devicescollaborator
- Kaneka Medical America LLCcollaborator
- Asahi Intechcollaborator
- Terumo Medical Corporationcollaborator
- Japan Lifelinecollaborator
Study Sites (25)
Toyohashi Heart Center
Toyohashi, Aichi-ken, Japan
The Jikei University Kashiwa Hospital
Kashiwa, Chiba, Japan
Tokai University
Isehara, Kanagawa, 259-1193, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Mie Heart Center
Taki-gun, Mie-ken, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Tohoku Koseinenkin Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Kansan Rosai Hospital
Amagasaki, Japan
Aomori Central Hospital
Aomori, Japan
Tsuchiya General Hospital
Hiroshima, Japan
Kokura Kinen hospital
Kitakyushu, Japan
Takahashi Hospital
Kobe, Japan
Kurune University Hospital
Kurume, Japan
Kyoto University
Kyoto, Japan
Iwate Prefectual Central Hospital
Morioka, Japan
Hyogo College of Medicine
Nishinomiya, Japan
Toho University Omori Medical Hospital Center
Ōta-ku, Japan
Hoshi General Hospital
Sapporo, Japan
Sapporo Higashi Tokushukai
Sapporo, Japan
Tokeidai Hospital
Sapporo, Japan
Shizuoka General Hospital
Shizuoka, Japan
Tenri Hospital
Tenri, Japan
Wakayama Medical University
Wakayama, Japan
Yokohama Sakae Kyosai Hospital
Yokohama, Japan
Related Publications (1)
Ikari Y, Awata M, Mitsudo K, Akasaka T, Saito S, Ishihara T, Fujii T, Hashimoto H, Terashima M, Ikemoto T, Hibi K, Tazaki J, Nakamura A, Nishikawa H, Sato T, Nakagawa Y. Efficient distal tip size of primary guidewire for antegrade percutaneous coronary intervention in chronic total occlusion: The G-FORCE study. Int J Cardiol. 2017 Jan 15;227:94-99. doi: 10.1016/j.ijcard.2016.11.076. Epub 2016 Nov 9.
PMID: 27855293DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuji Ikari, MD, PhD
Tokai University
- PRINCIPAL INVESTIGATOR
Kazuaki Mitsudo, MD
Kurashiki Central Hospital
- PRINCIPAL INVESTIGATOR
Osamu Kato, MD
Toyohashi Heart Center
- PRINCIPAL INVESTIGATOR
Shigeru Saito, MD
Shonan Kamakura General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Cardiology
Study Record Dates
First Submitted
September 29, 2009
First Posted
October 1, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 4, 2015
Record last verified: 2015-05