ongoing

The UNIVERSAL study is 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.

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.

Primary endpoints:

  • Incidence of major vascular complications [ Time Frame: up to 30 days post-procedure ]
  • Femoral artery pseudonaneurysm
  • Arteriovenous fistula
  • Retroperitoneal bleed
  • Major bleed based on BARC III criteria
  • Hematoma with more than 5 cm of diameter.
UNIVERSAL Slides - Download PDF
Study Type

Interventional - Procedure

Study Design

Parallel assignment, double masking RCT

NO. of Countries

1

NO. of Sites

1

NO. of Participants

1538 target

Study Period

2018-2020

Sponsor

PHRI

Hamilton Health Sciences

Innovation Fund, Division of Cardiology, Department of Medicine, McMaster University (2018)

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