Guidewire for Chronic Total Occlusion (G-FORCE)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Abbott Vascular
Kaneka Medics
Asahi Intech
Terumo
Japan Lifeline
Information provided by:
Tokai University
ClinicalTrials.gov Identifier:
NCT00987610
First received: September 29, 2009
Last updated: July 20, 2011
Last verified: October 2009
  Purpose

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 Intervention Phase
Coronary Occlusion
Device: Percutaneous coronary intervention (PCI)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion

Resource links provided by NLM:


Further study details as provided by Tokai University:

Primary Outcome Measures:
  • Lesion penetration rate of a first-choice guidewire [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Successful PCI rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Types of guidewires successfully passing through the lesion [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 290
Study Start Date: October 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: slender guidewire
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
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987610

Locations
Japan
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
Tohoku Koseinenkin Hospital
Sendai, Miyagi, Japan
Sendai Kousei 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 Medics
Asahi Intech
Terumo
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
Principal Investigator: Shigeru Saito, MD Shonan Kamakura General Hospital
  More Information

No publications provided

Responsible Party: Yuji Ikari, Professor, Tokai University
ClinicalTrials.gov Identifier: NCT00987610     History of Changes
Other Study ID Numbers: G-FORCE
Study First Received: September 29, 2009
Last Updated: July 20, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on August 28, 2014