Guidewire for Chronic Total Occlusion

NCT ID: NCT00987610

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

slender guidewire

Percutaneous coronary intervention (PCI) using guidewires with small distal tip equal to 0.010 inch or less

Group Type: ACTIVE_COMPARATOR

Percutaneous coronary intervention (PCI)

Intervention Type: DEVICE

PCI for chronic total occlusion is performed using either arm of guidewire

normal guidewire

Percutaneous coronary intervention (PCI) using guidewires with normal distal tip equal to 0.014 inch

Group Type: ACTIVE_COMPARATOR

Percutaneous coronary intervention (PCI)

Intervention Type: DEVICE

PCI for chronic total occlusion is performed using either arm of guidewire

Interventions

Percutaneous coronary intervention (PCI)

PCI for chronic total occlusion is performed using either arm of guidewire

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Kaneka Medical America LLC

INDUSTRY

Sponsor Role: collaborator

Asahi Intech

UNKNOWN

Sponsor Role: collaborator

Terumo Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Japan Lifeline

UNKNOWN

Sponsor Role: collaborator

Tokai University

OTHER

Sponsor Role: lead

Responsible Party

Yuji Ikari

Professor, Department of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuji Ikari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokai University

Kazuaki Mitsudo, MD

Role: PRINCIPAL_INVESTIGATOR

Kurashiki Central Hospital

Osamu Kato, MD

Role: PRINCIPAL_INVESTIGATOR

Toyohashi Heart Center

Shigeru Saito, MD

Role: PRINCIPAL_INVESTIGATOR

Shonan Kamakura General Hospital

Locations

Toyohashi Heart Center

Toyohashi, Aichi-ken, Japan

The Jikei University Kashiwa Hospital

Kashiwa, Chiba, Japan

Tokai University

Isehara, Kanagawa, 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

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 27855293 (View on PubMed)

Other Identifiers

G-FORCE

Identifier Type: -

Identifier Source: org_study_id