Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL)

Population Health Research Institute (PHRI)

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction

Treatments: Procedure: Fluoroscopic + Ultrasound Guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT03537118

UNIVERSAL.2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 621 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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621 participants in 2 patient groups

Fluoroscopic + Ultrasound Guidance

Experimental group

Treatment:

Procedure: Fluoroscopic + Ultrasound Guidance

Fluoroscopic Guidance Alone

No Intervention group