Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures: a Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 621
- Locations
- 1
- Primary Endpoint
- Incidence of major vascular complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Absence of palpable femoral pulse
Arms & Interventions
Fluoroscopic + Ultrasound Guidance
Intervention: Fluoroscopic + Ultrasound Guidance (Procedure)
Fluoroscopic Guidance Alone
Outcomes
Primary Outcomes
Incidence of major vascular complications
Time Frame: 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 Outcomes
No secondary outcomes reported