None listed
Conditions
Brief summary
Rationale: Transradial access for coronary angiogram is now standard for coronary angiography. It requires a guidewire to be directed up the radial artery to the aortic root to allow safe mobilization of catheters over it into the aorta to complete the procedure. The traditional guidewire made for femoral angiograms and predating transradial angiography is the peripheral 0.035” fixed core PTFE J-tipped wire (FC0.035) with a 3mm J tip curve radius. Radial arteries are smaller than femoral arteries and typically range from 2.2mm in diameter in women, to 2.7mm in men, both smaller than the J tip curve radius of 3mm in the FC0.035 wire which may predispose to radial spasm or vessel trauma. The hydrophilic J tip ‘baby J’ guidewire with a 1.5mm J tip radius has been designed to traverse areas of radial tortuosity and stenosis easier aiming for less spasm to improve success of passing catheters to the aortic root and is commonly used in coronary angiographic suites second line. However, the FC0.035 wire is still the traditional wire used in transradial coronary angiography, and direct comparison of their procedural success has not been studies to date. If indeed the baby J wire was demonstrated to have a higher success rate in gaining access to the aortic root compared to the FC0.035 wire, it would lead to less wire changes, and less need for alternate arterial punctures and subsequent predisposition to further vascular complications. If this were the case it would suggest it the baby J wire should be considered for use first line in transradial coronary angiography. The objective of this study is to determine if use of the baby J guidewire in transradial coronary angiogram has any difference in technical success compared to the traditionally used FC0.035” wire. The study design is a prospective randomised controlled trial with intention to treat analysis. The study population consists of Participants undergoing best practice coronary angiography or percutaneous intervention at Gosford District Hospital who consent to become enrolled in the trial. At least three hundred and ten Participants are aimed to be enrolled over 12 months. The main study endpoints include the primary outcome of technical success rates between guidewires. Secondary outcomes include crossover to alternative peripheral wire, crossover to alternative access site, bleeding rates (BARC criteria), vascular complications (VARC 2 criteria), radial spasm, haematoma formation (EASY criteria) time to wire entry of subclavian, aorta, and selective coronary intubation.
Interventions
Transradial coronary angiogram involves passing a catheter and guidewire through an initially inserted radial artery sheath to traverse up arterial system eventually into the aortic root. The guidewire is passed first being less traumatic than a catheter as to not cause vessel damage, then a catheter is railroaded over the guidewire to gain entry to the aorta. Completion of the angiogram involves mobilising the catheters into coronary arteries and injecting contrast which can be captured under f
Transradial coronary angiogram involves passing a catheter and guidewire through an initially inserted radial artery sheath to traverse up arterial system eventually into the aortic root. The guidewire is passed first being less traumatic than a catheter as to not cause vessel damage, then a catheter is railroaded over the guidewire to gain entry to the aorta. Completion of the angiogram involves mobilising the catheters into coronary arteries and injecting contrast which can be captured under fluoroscopic imaging. If results determine percutaneous intervention (stenting) needs to occur, catheters can be exchanged at this time and the procedure can take place. Coronary angiograms can take anywhere from 15 minutes to a few hours depending on what intervention needs to take place. Once the radial sheath is inserted, traversing a guidewire and catheter to the aortic root can take as little as 10 to 20 seconds if a patient has favourable anatomy by the performing Cardiology Advanced Trainee or Cardiologist. If arterial tortuosity, stenosis or significant spasm are present, this can lead to difficulty or even inability to pass wires and catheters to the aorta. This can increase the duration of the procedure, predispose to arterial trauma, increase the amount of contrast needed or result in the need for alternate arterial access increasing risk of procedural complications. Multiple guidewires exist which aid in the initial mobilisation of the angiogram catheter to the aorta. The traditionally wire was initially designed for femoral angiograms using larger arteries. Now that transradial is best practice method for coronary angiograms, alternate smaller and hydrophilic wires have been designed with suggestion they may help traverse the transradial arterial anatomy. We seek to determine if a hydrophilic J tipped 1.5mm 0.035” peripheral access wire (‘Baby J’ Glidewire, Terumo systems, Japan) is more successful that the larger traditionally used standard 3mm J tipped 0.035 guidewire in gaining access to the aorta to enable successful coronary angiogram. The procedure is observed by the radiographer do document procedure success and is verbally confirmed between the radiographer and Interventionalist at the completion of the procedure.
Sponsors
Gosford Hospital CCLHD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Age greater than or equal to 18 years old 2) Undergoing planned best practice transradial coronary angiography at Gosford District Hospital 3) Expected to have transradial access to coronary angiography prior to the procedure 4) Radial sheath able to be inserted for transradial access 5) Provide written informed consent before study participation.
Exclusion criteria
1) Obligatory femoral access 2) Previous ipsilateral forearm radial artery occlusion. 3) Emergency/salvage coronary angiography where consent cannot be obtained. 4) Enrolment in an alternate study that competes or interferes with this study. 5) Any other condition which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study. 6) Inability to provide informed consent for themselves.
Outcome results
None listed