Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia
Conditions
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.
Interventions
PROCEDUREFluoroscopic + Ultrasound Guidance
Fluoroscopic Guidance Alone
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient referred for coronary angiography or percutaneous coronary intervention (PCI) in whom femoral access is planned. 2. Planned femoral access
Exclusion criteria
1. Age ≤ 18 years 2. STEMI 3. Absence of palpable femoral pulse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed