Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures
Not Applicable
Completed
- Conditions
- Myocardial InfarctionMyocardial IschemiaCoronary Artery Disease
- Interventions
- Procedure: Fluoroscopic + Ultrasound Guidance
- Registration Number
- NCT03537118
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
A randomized, controlled trial to determine whether the use of ultrasound guidance for vascular access during coronary angiography or percutaneous coronary intervention (PCI) will reduce the rates of major vascular complications.
- Detailed Description
Patients who will undergo a coronary angiography or PCI using femoral access will be allocated to either: 1) femoral access using fluoroscopic and ultrasound guidance, or 2) femoral access using fluoroscopic guidance alone.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 621
Inclusion Criteria
- Patient referred for coronary angiography or percutaneous coronary intervention (PCI) in whom femoral access is planned.
- Planned femoral access
Exclusion Criteria
- Age ≤ 18 years
- STEMI
- Absence of palpable femoral pulse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluoroscopic + Ultrasound Guidance Fluoroscopic + Ultrasound Guidance -
- Primary Outcome Measures
Name Time Method Incidence of major vascular complications up to 30 days post-procedure Femoral artery pseudoaneurysm, AV fistula, retroperitoneal bleed, large hematoma (\>5 cm), ischemic limb requiring intervention or surgery, or major bleed based on BARC II, III, or V criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada