Track topics on Twitter Track topics that are important to you
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percutaneous coronary intervention (PCI)
Toyohashi Heart Center
Published on BioPortfolio: 2014-07-24T14:11:21-0400
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...
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 ...
The investigators aim to evaluate circulating irisin levels alterations in patients with acute myocardial infraction and in patients with coronary artery disease subjected to percutaneous ...
Same day discharge is safe and feasible in selected troponin negative patients undergoing coronary planned percutaneous coronary intervention (PCI) or ad hoc PCI via the transfemoral appro...
To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population. The hypothesis to be tested is tha...
Percutaneous coronary intervention (PCI) for coronary artery chronic total occlusion (CTO) is an important treatment to be used in conjunction with non-CTO PCI, coronary artery bypass grafting, and op...
Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) has undergone impressive progress during the last decade, both in strategies and equipment. It is unknown whether technical r...
We sought to examine contemporary perspectives and practices on chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Cardiovascular disease (CVD) is the major cause of mortality worldwide. Coronary artery disease (CAD) contributes to half of mortalities caused by CVD. The mainstay of management of CAD is medical the...
In patients with left main coronary artery (LMCA) stenosis, coronary artery bypass grafting (CABG) has been the standard therapy for several decades. However, some studies suggest that percutaneous co...
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.
A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.
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...