Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

Not Applicable

Completed

• Conditions: Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease

• Registration Number: NCT03537118
• Lead Sponsor: Population Health Research Institute

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.

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-25
• Study Start: 2018-06-20
• Primary Completion: 2022-05-30
• Study Completion: 2022-07-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 621

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of major vascular complications	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

Trial Locations

Locations (1)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada