Clinical trial NCT00987610: Guidewire for Chronic Total Occlusion
Official title: Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Occlusion
Keywords: Percutaneous coronary intervention
chronic total occlusion
guidewire
Angioplasty, Transluminal, Percutaneous Coronary
Angioplasty
Percutaneous Coronary
Lead sponsor: Tokai University
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Kaneka Medical America LLC
name: Asahi Intech
name: Terumo Medical Corporation
name: Japan Lifeline
First posted: 2009-10-01
Enrollment: 260
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lesion penetration rate of a first-choice guidewire
timeFrame: 30 days
Secondary outcomes:
measure: Successful PCI rate
timeFrame: 30 days
measure: Types of guidewires successfully passing through the lesion
timeFrame: 30 days
measure: Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures)
timeFrame: 30 days
Other outcomes:
Locations:
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
state: Aichi
city: Kashiwa
country: Japan
facility: The Jikei University Kashiwa Hospital
state: Chiba
city: Isehara
country: Japan
facility: Tokai University
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Taki-gun
country: Japan
facility: Mie Heart Center
state: Mie
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku Koseinenkin Hospital
state: Miyagi
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Amagasaki
country: Japan
facility: Kansan Rosai Hospital
city: Aomori
country: Japan
facility: Aomori Central Hospital
city: Hiroshima
country: Japan
facility: Tsuchiya General Hospital
city: Kitakyusyu
country: Japan
facility: Kokura Kinen hospital
city: Kobe
country: Japan
facility: Takahashi Hospital
city: Kurume
country: Japan
facility: Kurune University Hospital
city: Kyoto
country: Japan
facility: Kyoto University
city: Morioka
country: Japan
facility: Iwate Prefectual Central Hospital
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
city: Ota
country: Japan
facility: Toho University Omori Medical Hospital Center
city: Sapporo
country: Japan
facility: Hoshi General Hospital
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai
city: Sapporo
country: Japan
facility: Tokeidai Hospital
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
city: Tenri
country: Japan
facility: Tenri Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University
city: Yokohama
country: Japan
facility: Yokohama Sakae Kyosai Hospital
Study officials:
affiliation: Tokai University
name: Yuji Ikari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kurashiki Central Hospital
name: Kazuaki Mitsudo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toyohashi Heart Center
name: Osamu Kato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shonan Kamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.