Guidewire for Chronic Total Occlusion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion

Conditions
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Coronary Occlusion

Intervention / Treatment
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* Device: Percutaneous coronary intervention (PCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic total occlusion (CTO) lesion in native coronary artery De novo lesion Elective procedure Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: slender guidewire<br>Percutaneous coronary intervention (PCI) using guidewires with small distal tip equal to 0.010 inch or less | Device: Percutaneous coronary intervention (PCI)<br>* PCI for chronic total occlusion is performed using either arm of guidewire<br>|
| Active Comparator: normal guidewire<br>Percutaneous coronary intervention (PCI) using guidewires with normal distal tip equal to 0.014 inch | Device: Percutaneous coronary intervention (PCI)<br>* PCI for chronic total occlusion is performed using either arm of guidewire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion penetration rate of a first-choice guidewire |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, chronic total occlusion, guidewire, Angioplasty, Transluminal, Percutaneous Coronary, Angioplasty, Percutaneous Coronary