Guidewire for Chronic Total Occlusion (G-FORCE)

May 1, 2015 updated by: Yuji Ikari, Tokai University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Amagasaki, Japan
        • Kansan Rosai Hospital
      • Aomori, Japan
        • Aomori Central Hospital
      • Hiroshima, Japan
        • Tsuchiya General Hospital
      • Kitakyusyu, Japan
        • Kokura Kinen Hospital
      • Kobe, Japan
        • Takahashi Hospital
      • Kurume, Japan
        • Kurune University Hospital
      • Kyoto, Japan
        • Kyoto University
      • Morioka, Japan
        • Iwate Prefectual Central Hospital
      • Nishinomiya, Japan
        • Hyogo College of Medicine
      • Ota, Japan
        • Toho University Omori Medical Hospital Center
      • Sapporo, Japan
        • Hoshi General Hospital
      • Sapporo, Japan
        • Sapporo Higashi Tokushukai
      • Sapporo, Japan
        • Tokeidai Hospital
      • Shizuoka, Japan
        • Shizuoka General Hospital
      • Tenri, Japan
        • Tenri Hospital
      • Wakayama, Japan
        • Wakayama Medical University
      • Yokohama, Japan
        • Yokohama Sakae Kyosai Hospital
    • Aichi
      • Toyohashi, Aichi, Japan
        • Toyohashi Heart Center
    • Chiba
      • Kashiwa, Chiba, Japan
        • The Jikei University Kashiwa Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University
      • Kamakura, Kanagawa, Japan
        • Shonan Kamakura General Hospital
    • Mie
      • Taki-gun, Mie, Japan
        • Mie Heart Center
    • Miyagi
      • Sendai, Miyagi, Japan
        • Sendai Kousei Hospital
      • Sendai, Miyagi, Japan
        • Tohoku Koseinenkin Hospital
    • Okayama
      • Kurashiki, Okayama, Japan
        • Kurashiki Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Successful PCI rate
Time Frame: 30 days
30 days
Types of guidewires successfully passing through the lesion
Time Frame: 30 days
30 days
Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures)
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokai University

Collaborators

Abbott Medical Devices
Kaneka Medical America LLC
Terumo Medical Corporation
Asahi Intech
Japan Lifeline

Investigators

  • Principal Investigator: Yuji Ikari, MD, PhD, Tokai University
  • Principal Investigator: Kazuaki Mitsudo, MD, Kurashiki Central Hospital
  • Principal Investigator: Osamu Kato, MD, Toyohashi Heart Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimate)

October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-FORCE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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