Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

Population Health Research Institute621 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

621

Conditions

Myocardial Infarction Coronary Artery Disease Myocardial Ischemia

Interventions

Fluoroscopic + Ultrasound GuidancePROCEDURE

Fluoroscopic Guidance Alone

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Hamilton Health Sciences

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: up to 30 days post-procedure

Data from ClinicalTrials.gov

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