Guidewire for Chronic Total Occlusion

2014-07-24 14:11:21 | BioPortfolio


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.


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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Coronary Occlusion


Percutaneous coronary intervention (PCI)


Toyohashi Heart Center




Tokai University

Results (where available)

View Results


Published on BioPortfolio: 2014-07-24T14:11:21-0400

Clinical Trials [3705 Associated Clinical Trials listed on BioPortfolio]

Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion

The aim of this study is to investigate the role of functional evaluation for predicting clinical outcome in patients with coronary chronic total occlusion (CTO) undergoing percutaneous co...

Change in Exercise Capacity as Measured by Peak Oxygen Uptake After CTO PCI

The purpose of this project is to objectively assess the change (improvement) in exercise capacity in patients undergoing routine percutaneous coronary intervention (PCI) for chronic total...

Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis

This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.

Computed Tomography Angiography Prediction Score for Side Branch Occlusion

Lesions involving coronary bifurcations account for approximately 20% of all percutaneous coronary interventions (PCI). Revascularization within bifurcation sites remains technically chall...

Prospective Registry to Assess the Cath Lab Percutaneous Coronary Intervention Long-term Outcomes: a Single Center

The registry study is to obtain the state of the percutaneous coronary intervention state treatment for coronary heart disease in the center of the first hospital of sun yat-sen unversity ...

PubMed Articles [6145 Associated PubMed Articles listed on BioPortfolio]

Use of sodium nitroprusside in retrograde percutaneous coronary intervention for chronic total occlusion: A case report.

Chronic total occlusion continues to be a challenging lesion subset for percutaneous coronary intervention.

Challenges adhering to a medication regimen following first-time percutaneous coronary intervention: A patient perspective.

Percutaneous coronary intervention is the most common therapeutic intervention for patients with narrowed coronary arteries due to coronary artery disease. Although it is known that patients with coro...

Myocardial Revascularization Trials.

This article reviews the context and evidence of recent myocardial revascularization trials that compared percutaneous coronary intervention with coronary artery bypass grafting for the treatment of l...

Procedure failure of chronic total occlusion percutaneous coronary intervention in an algorithm driven contemporary Asia-Pacific Chronic Total Occlusion Club (APCTO Club) multicenter registry.

With the evolution of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) technique and equipment, the success rate of CTO PCI has improved over the years. We examined the failed ca...

Coronary Artery Tenting After Bypass Grafting: A Key Issue During Percutaneous Coronary Intervention of a Chronic Total Occlusion.

This image series shows how bypass grafts may tent the vessel to which they are anastomosed, potentially changing the expected course of the native coronary vessel. This fact must be taken into accoun...

Medical and Biotech [MESH] Definitions

A family of percutaneous techniques that are used to manage CORONARY OCCLUSION, including standard balloon angioplasty (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY), the placement of intracoronary STENTS, and atheroablative technologies (e.g., ATHERECTOMY; ENDARTERECTOMY; THROMBECTOMY; PERCUTANEOUS TRANSLUMINAL LASER ANGIOPLASTY). PTCA was the dominant form of PCI, before the widespread use of stenting.

Complete blockage of blood flow through one of the CORONARY ARTERIES, usually from CORONARY ATHEROSCLEROSIS.

Dilatation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.

Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.


More From BioPortfolio on "Guidewire for Chronic Total Occlusion"

Quick Search


Relevant Topic

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Searches Linking to this Trial