Percutaneous Coronary Intervention in patients with coronary artery disease using assisted robotic technology: a randomised controlled trial
Not Applicable
Recruiting
- Conditions
- Coronary artery diseaseCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12623000480684
- Lead Sponsor
- South Western Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method We will compare patient radiation exposure (as measured via individual dosimeters) between those undergoing PCI via robotic approach to those undergoing PCI via manual approach[ Immediately post procedure ]
- Secondary Outcome Measures
Name Time Method Clinical success which is defined as less than 30% residual stenosis (visual estimate) post PCI, without in-hospital major adverse coronary events (MACE). Possible adverse events of note including death, myocardial infarction, stent thrombosis, target lesion revascularisation, arrhythmia, serious bleeding, contrast induced nephropathy or vascular injury. These adverse events will be screened by the clinical team at the end of the PCI procedure, at discharge (or day 3 whichever occurs first) and phone calls at Day 30 and Day 365 or review of medical records. The events will then be reviewed by a blinded and independent adjudication committee.[ End of PCI procedure, day 3, day 30 and day 365]