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NCT03537118 Clinical Trial

Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

Coronary Artery Disease Clinical Trial

— UNIVERSAL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03537118
Other study ID # UNIVERSAL.2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2018
Est. completion date July 15, 2022

Study information
Verified date August 2022
Source Population Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 621
Est. completion date July 15, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Fluoroscopic + Ultrasound Guidance
Fluoroscopic Guidance Alone

Locations
Country Name City State
Canada Hamilton Health Sciences Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of major vascular complications 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 up to 30 days post-procedure
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