None listed
Conditions
Brief summary
Coronary artery disease is a leading cause of death globally, nationally and locally. Currently in South Western Sydney Local Health District Interventional Cardiologists perform Percutaneous Coronary intervention (PCI) procedure which opens coronary arteries that are narrowed or blocked by the build-up of atherosclerotic plaque. PCI may also be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack. With new technology, engineering and training development, a technology-assisted percutaneous coronary intervention (PCI) device has the potential to increase procedural accuracy, reduce radiation exposure to patients and staff, improved ergonomics, and reduce major adverse cardiac events. To date we are not aware of any randomised controlled trial data supporting this technology
Interventions
The two treatment arms are 1. patients undergoing PCI with robotic assistance and 2. patients undergoing PCI via manual (traditional approach). All patients undergoing PCI will be asked to participate in this clinical trial which compares robotic PCI versus manual standard PCI. These procedures will be performed face to face in our hospital by interventional cardiologists specifically trained to operate the robot with a minimum of 5 supervised cases performed already. The PCI procedure requires
The two treatment arms are 1. patients undergoing PCI with robotic assistance and 2. patients undergoing PCI via manual (traditional approach). All patients undergoing PCI will be asked to participate in this clinical trial which compares robotic PCI versus manual standard PCI. These procedures will be performed face to face in our hospital by interventional cardiologists specifically trained to operate the robot with a minimum of 5 supervised cases performed already. The PCI procedure requires the injection of iodine based contrast and use of X rays to visualise the coronary arteries and the areas of stenosis (narrowing). The duration of these procedures can vary from 1-4 hours depending on the number of lesions and their complexity. The amount of dye to be injected varies depending on how many angiogram pictures are required. Patients participating will either be hospital inpatients or outpatients attending for day only procedures. Most patients will have only one procedure however patient will multiple lesions requiring PCI may return for multiple PCI procedures. Whether or not all the lesions are treated with the robot (or by a hybrid of manual and robotic PCI) will be at the discretion of the treating cardiologist. Patients will be followed up for clinical outcomes until hospital discharge or 72hrs (whichever occurs first), at day 30 and day 365. The day 30 and day 365 reviews will be completed over the phone.
Sponsors
South Western Sydney Local Health District
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 85 Years
Healthy volunteers
No
Inclusion criteria
• Age between 18 years to 85 years • Patients with coronary artery disease with clinical indication for PCI • Patient deemed appropriate for robotic-assisted PCI • Provided a signed and dated informed consent form
Exclusion criteria
None
Outcome results
None listed