Enhancing Guidewire Efficacy for transradial access: The EAGER Randomised Controlled Trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: 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 anatom CONDITION: Cardiovascular ‐ Other cardiovascular diseases Transradial Coronary Angiography; ; Transradial Coronary Angiography PRIMARY OUTCOME: The primary endpoint is technical success ‐ we define this as successful wire passage into aortic root without crossover to alternate guidewire or access site. This will be recorded by the Cath lab radiographer or angiogram procedurals on a data entry sheet who will be trained in study protocol.[At completion of the coronary angiogram.] 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. SECONDARY OUTCOME: Crossover to alternative peripheral wire ; Collected by Cath lab radiographer who is educated on the study protocol[By completion of coronary angiogram ; Collected by Cath lab radiographer who is educated on the study protocol] Overall Bleeding complications – Bleeding academic research consortium (BARC) criteria ; Recorded by Cath lab nursing staff who are educated in study protocol [Assessed for up to 1 month post procedure] Procedure time. Collected by Cath lab radiographer who is educated on the study protocol[By completion of coronary angiogram ] Puncture Site bleeding complications (haematoma) formation ‐ Collected in data entry sheet by Cath lab nursing staff on the day of angiography, or noted in the 4 week electronic medical record review by the study doctor.[Assessed for up to 1 month post procedure] Radial spasm ‐ Recorded by radiographer on data collection sheet as directed by technician who will make decision of spasm encountered[Assessed continuously throughout the coronary angiogram procedure] Time to access aorta ‐ Recorded by radiographer in data entry form.[By completion of coronary angiogram ] Time to selective coronary intubation ; Collected by Cath lab radiographer who is educated on the study protocol[By completion of coronary angiogram ] Vascular complications – Valve academic research consortium ‐ 2 (VARC 2) criteria[Assessed for up to 1 month post procedure]
Epistemonikos ID: 14a35314c6da4ae74267383a013c6b603fdc9d8f
First added on: Aug 26, 2024