Guidewire for Chronic Total Occlusion

Coronary Occlusion Clinical Trial

— G-FORCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987610
• Other study ID #: G-FORCE
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2009
• Last updated: May 1, 2015
• Start date: October 2009
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Tokai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Occlusion

Intervention

Device:
• Percutaneous coronary intervention (PCI)
PCI for chronic total occlusion is performed using either arm of guidewire

Locations

Country	Name	City	State
Japan	Kansan Rosai Hospital	Amagasaki
Japan	Aomori Central Hospital	Aomori
Japan	Tsuchiya General Hospital	Hiroshima
Japan	Tokai University	Isehara	Kanagawa
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	The Jikei University Kashiwa Hospital	Kashiwa	Chiba
Japan	Kokura Kinen hospital	Kitakyusyu
Japan	Takahashi Hospital	Kobe
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
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	Ota
Japan	Hoshi General Hospital	Sapporo
Japan	Sapporo Higashi Tokushukai	Sapporo
Japan	Tokeidai Hospital	Sapporo
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	Tohoku Koseinenkin Hospital	Sendai	Miyagi
Japan	Shizuoka General Hospital	Shizuoka
Japan	Mie Heart Center	Taki-gun	Mie
Japan	Tenri Hospital	Tenri
Japan	Toyohashi Heart Center	Toyohashi	Aichi
Japan	Wakayama Medical University	Wakayama
Japan	Yokohama Sakae Kyosai Hospital	Yokohama

Sponsors (6)

Lead Sponsor	Collaborator
Tokai University	Abbott Vascular, Asahi Intech, Japan Lifeline, Kaneka Pharma America LLC, Terumo Medical Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion penetration rate of a first-choice guidewire		30 days	No
Secondary	Successful PCI rate		30 days	Yes
Secondary	Types of guidewires successfully passing through the lesion		30 days	No
Secondary	Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures)		30 days	Yes