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

Population Health Research Institute1 site in 1 country621 target enrollmentJune 20, 2018

ConditionsMyocardial Infarction Coronary Artery Disease Myocardial Ischemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myocardial Infarction
Sponsor: Population Health Research Institute
Enrollment: 621
Locations: 1
Primary Endpoint: Incidence of major vascular complications
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 20, 2018

End Date

July 15, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Population Health Research Institute

Responsible Party

Sponsor

Eligibility Criteria

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

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