Guidewire for Chronic Total Occlusion (G-FORCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00987610
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : May 4, 2015
Abbott Vascular
Kaneka Pharma America LLC
Asahi Intech
Terumo Medical Corporation
Japan Lifeline
Information provided by (Responsible Party):
Yuji Ikari, Tokai University

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.

Condition or disease Intervention/treatment Phase
Coronary Occlusion Device: Percutaneous coronary intervention (PCI) Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion
Study Start Date : October 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Active Comparator: slender guidewire
Percutaneous coronary intervention (PCI) using guidewires with small distal tip equal to 0.010 inch or less
Device: Percutaneous coronary intervention (PCI)
PCI for chronic total occlusion is performed using either arm of guidewire

Active Comparator: normal guidewire
Percutaneous coronary intervention (PCI) using guidewires with normal distal tip equal to 0.014 inch
Device: Percutaneous coronary intervention (PCI)
PCI for chronic total occlusion is performed using either arm of guidewire

Primary Outcome Measures :
  1. Lesion penetration rate of a first-choice guidewire [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Successful PCI rate [ Time Frame: 30 days ]
  2. Types of guidewires successfully passing through the lesion [ Time Frame: 30 days ]
  3. Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures) [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00987610

Toyohashi Heart Center
Toyohashi, Aichi, Japan
The Jikei University Kashiwa Hospital
Kashiwa, Chiba, Japan
Tokai University
Isehara, Kanagawa, Japan, 259-1193
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Mie Heart Center
Taki-gun, Mie, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Tohoku Koseinenkin Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki, Okayama, Japan
Kansan Rosai Hospital
Amagasaki, Japan
Aomori Central Hospital
Aomori, Japan
Tsuchiya General Hospital
Hiroshima, Japan
Kokura Kinen hospital
Kitakyusyu, 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
Ota, 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
Sponsors and Collaborators
Tokai University
Abbott Vascular
Kaneka Pharma America LLC
Asahi Intech
Terumo Medical Corporation
Japan Lifeline
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yuji Ikari, Professor, Department of Cardiology, Tokai University Identifier: NCT00987610     History of Changes
Other Study ID Numbers: G-FORCE
First Posted: October 1, 2009    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: May 2015

Keywords provided by Yuji Ikari, Tokai University:
Percutaneous coronary intervention
chronic total occlusion
Angioplasty, Transluminal, Percutaneous Coronary
Percutaneous Coronary

Additional relevant MeSH terms:
Coronary Occlusion
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases