Coronary OcclusionPhase 4G-FORCENCT00987610
Guidewire for Chronic Total Occlusion
A Phase 4 study testing Percutaneous coronary intervention (PCI) in people with Coronary Occlusion, run by Tokai University at 25 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Occlusion
- What is being tested?
- Percutaneous coronary intervention (PCI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 25 sitesJapan
- Study dates
- Oct 2009to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic total occlusion (CTO) lesion in native coronary artery
- De novo lesion
- Elective procedure
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Kansan Rosai Hospital
Amagasaki
Aomori Central Hospital
Aomori
Tsuchiya General Hospital
Hiroshima
Tokai University
Isehara, Kanagawa, 259-1193
Shonan Kamakura General Hospital
Kamakura, Kanagawa
The Jikei University Kashiwa Hospital
Kashiwa, Chiba
Kokura Kinen hospital
Kitakyushu
Takahashi Hospital
Kobe
Kurashiki Central Hospital
Kurashiki, Okayama-ken
Kurune University Hospital
Kurume
Kyoto University
Kyoto
Iwate Prefectual Central Hospital
Morioka
Hyogo College of Medicine
Nishinomiya
Toho University Omori Medical Hospital Center
Ōta-ku
Hoshi General Hospital
Sapporo
Sapporo Higashi Tokushukai
Sapporo
Tokeidai Hospital
Sapporo
Sendai Kousei Hospital
Sendai, Miyagi
Tohoku Koseinenkin Hospital
Sendai, Miyagi
Shizuoka General Hospital
Shizuoka
Mie Heart Center
Taki-gun, Mie-ken
Tenri Hospital
Tenri
Toyohashi Heart Center
Toyohashi, Aichi-ken
Wakayama Medical University
Wakayama
Yokohama Sakae Kyosai Hospital
Yokohama
About this study
Official title: Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion
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.
Read the detailed description
Background. Although the success rate of PCI for CTO is yet to reach a satisfactory level, prognoses have been improved in successful cases. The greatest challenge is the passage of the guidewire and a variety of new approaches including a parallel wire technique and a retrograde approach have been reported. However, the fundamental question of what type of guidewire is the most appropriate as a first-choice guidewire has not been answered.Tapered guidewires have recently been reported to be useful for CTO lesions. In addition, a multicenter prospective registry indicates the effectiveness of 0.010-inch guidewires (PIKACHU registry, personal communication). Its mechanism is associated with micro-channels ranging from 100 to 300 μm in size in CTO lesions. If 250 μm micro-channels are present in 60% of CTO lesions, a 0.010-inch (equivalent to 250 μm) guidewire theoretically can pass through the lesion at the probability of 60%, and this assumption consists with the findings of the PIKACHU study. This idea also suggests that a 0.014-inch (350 μm) guidewire is unlikely to pass through lesions.
Based on the above, a hypothesis has been formulated that a guidewire with a small tip should be selected as a first-choice guidewire for CTO lesions. In this study, patients will be prospectively randomized to slender guidewires or standard 0.014-inch guidewires to determine appropriate first-choice guidewires.
Objective. To determine appropriate first-choice guidewires.
Design. Prospective multicenter randomized controlled trial
Methods. The first choice guidewire to treat CTO lesion was randomly assigned to normal group (distal tip size 0.014 inch) or slender group (distal tip size 0.010 inch or less). The primary passage must be performed with antegrade approach.
Primary endpoint. Lesion penetration rate of a first-choice guidewire
Power calculation. The PIKACHU registry indicates a 0.010 guidewire passes through a lesion with a success rate of 60%. Assuming the penetration rate of a 0.014 guidewire is 40%, a necessary number of patients would be 260 for a two-sided test with 90% power and significance level of 0.05. Assuming the dropout rate is approximately 10%, the target sample size would be 290 patients.
- Conditions
- Coronary Occlusion
- Being tested
- Percutaneous coronary intervention (PCI)
- Keywords
- Percutaneous coronary intervention, chronic total occlusion, guidewire, Angioplasty, Transluminal, Percutaneous Coronary, Angioplasty, Percutaneous Coronary
- Medical subject headings
- Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Device
PCI for chronic total occlusion is performed using either arm of guidewire
| Study group | Role | What they receive |
|---|---|---|
| slender guidewire | Active comparator | Percutaneous coronary intervention (PCI) using guidewires with small distal tip equal to 0.010 inch or less Receives: Device: Percutaneous coronary intervention (PCI) |
| normal guidewire | Active comparator | Percutaneous coronary intervention (PCI) using guidewires with normal distal tip equal to 0.014 inch Receives: Device: Percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion penetration rate of a first-choice guidewire
Measured: 30 days
Secondary outcomes (3)
Successful PCI rate
Measured: 30 days
Types of guidewires successfully passing through the lesion
Measured: 30 days
Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokai University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Kaneka Medical America LLC, Asahi Intech, Terumo Medical Corporation, Japan Lifeline
- Responsible party
- Principal investigator, Yuji Ikari, Tokai University
- Investigators
- Yuji Ikari, MD, PhD, Principal investigator, Tokai UniversityKazuaki Mitsudo, MD, Principal investigator, Kurashiki Central HospitalOsamu Kato, MD, Principal investigator, Toyohashi Heart CenterShigeru Saito, MD, Principal investigator, Shonan Kamakura General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987610
- Sponsor's protocol ID
- G-FORCE
- Acronym
- G-FORCE
- Status last verified
- May 2015
- First submitted
- 29 Sep 2009
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27855293
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT00987610
- Acronym / sponsor ID
- G-FORCE / G-FORCE
- Conditions
- Coronary Occlusion
- Keywords
- Percutaneous coronary intervention, chronic total occlusion, guidewire, Angioplasty, Transluminal, Percutaneous Coronary, Angioplasty, Percutaneous Coronary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Tokai UniversityUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, Kaneka Medical America LLC, Asahi Intech, Terumo Medical Corporation, Japan Lifeline
- Study start
- Oct 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background. Although the success rate of PCI for CTO is yet to reach a satisfactory level, prognoses have been improved in successful cases. The greatest challenge is the passage of the guidewire and a variety of new approaches including a parallel wire technique and a retrograde approach have been reported. However, the fundamental question of what type of guidewire is the most appropriate as a first-choice guidewire has not been answered.Tapered guidewires have recently been reported to be useful for CTO lesions. In addition, a multicenter prospective registry indicates the effectiveness of 0.010-inch guidewires (PIKACHU registry, personal communication). Its mechanism is associated with micro-channels ranging from 100 to 300 μm in size in CTO lesions. If 250 μm micro-channels are present in 60% of CTO lesions, a 0.010-inch (equivalent to 250 μm) guidewire theoretically can pass through the lesion at the probability of 60%, and this assumption consists with the findings of the PIKACHU study. This idea also suggests that a 0.014-inch (350 μm) guidewire is unlikely to pass through lesions.
Based on the above, a hypothesis has been formulated that a guidewire with a small tip should be selected as a first-choice guidewire for CTO lesions. In this study, patients will be prospectively randomized to slender guidewires or standard 0.014-inch guidewires to determine appropriate first-choice guidewires.
Objective. To determine appropriate first-choice guidewires.
Design. Prospective multicenter randomized controlled trial
Methods. The first choice guidewire to treat CTO lesion was randomly assigned to normal group (distal tip size 0.014 inch) or slender group (distal tip size 0.010 inch or less). The primary passage must be performed with antegrade approach.
Primary endpoint. Lesion penetration rate of a first-choice guidewire
Power calculation. The PIKACHU registry indicates a 0.010 guidewire passes through a lesion with a success rate of 60%. Assuming the penetration rate of a 0.014 guidewire is 40%, a necessary number of patients would be 260 for a two-sided test with 90% power and significance level of 0.05. Assuming the dropout rate is approximately 10%, the target sample size would be 290 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| slender guidewire | Active comparator | Device: Percutaneous coronary intervention (PCI)Percutaneous coronary intervention (PCI) using guidewires with small distal tip equal to 0.010 inch or less |
| normal guidewire | Active comparator | Device: Percutaneous coronary intervention (PCI)Percutaneous coronary intervention (PCI) using guidewires with normal distal tip equal to 0.014 inch |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic total occlusion (CTO) lesion in native coronary artery
- De novo lesion
- Elective procedure
Key exclusion criteria (7 listed)
- No indication of PCI
- Prior failed lesion
- Restenotic or in-stent restenotic lesion
- Vein or arterial grafts
- Younger than 20 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary intervention (PCI)PCI for chronic total occlusion is performed using either arm of guidewire | Device | normal guidewire, slender guidewire |
Primary outcome
Lesion penetration rate of a first-choice guidewire
Time frame: 30 days
3 secondary outcomes
Successful PCI rate
Time frame: 30 days
Types of guidewires successfully passing through the lesion
Time frame: 30 days
Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Derived from this study: PubMed 27855293Ikari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuji Ikari, MD, PhD principal investigator
Tokai University
Kazuaki Mitsudo, MD principal investigator
Kurashiki Central Hospital
Osamu Kato, MD principal investigator
Toyohashi Heart Center
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous coronary intervention (PCI) in people with Coronary Occlusion, run by Tokai University at 25 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion penetration rate of a first-choice guidewire (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.