Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

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.

Completed

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Key information

Conditions

Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8L2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoroscopic + Ultrasound Guidance

Procedure

Fluoroscopic Guidance Alone

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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures: a Randomized Trial

Acronym: UNIVERSAL

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: May 25, 2018
Registry last updated: Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed