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CompletedNCT03537118UNIVERSALUpdated Aug 12, 2022

Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

An interventional study of Fluoroscopic + Ultrasound Guidance in Myocardial Infarction, Coronary Artery Disease and Myocardial Ischemia, sponsored by Population Health Research Institute. Completed at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-08-12.

Sponsored by Population Health Research Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
621
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Myocardial Infarction
  • Coronary Artery Disease
  • Myocardial Ischemia
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 621 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Age ≤ 18 years
  2. STEMI
  3. Absence of palpable femoral pulse
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
621 participants (actual)

Study arms

  • Experimental
    Fluoroscopic + Ultrasound Guidance

    Procedure: Fluoroscopic + Ultrasound Guidance

  • No intervention
    Fluoroscopic Guidance Alone

Interventions

  • ProcedureFluoroscopic + Ultrasound Guidance

    Fluoroscopic Guidance Alone

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What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Hamilton Health Sciences
    Hamilton, Ontario L8L2X2, Canada
08

References and documents

Publications

  • Jolly SS, AlRashidi S, d'Entremont MA, Alansari O, Brochu B, Heenan L, Skuriat E, Tyrwhitt J, Raco M, Tsang M, Valettas N, Velianou JL, Sheth T, Sibbald M, Mehta SR, Pinilla-Echeverri N, Schwalm JD, Natarajan MK, Kelly A, Akl E, Tawadros S, Camargo M, Faidi W, Bauer J, Moxham R, Nkurunziza J, Dutra G, Winter J. Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures: The UNIVERSAL Randomized Clinical Trial. JAMA Cardiol. 2022 Nov 1;7(11):1110-1118. doi: 10.1001/jamacardio.2022.3399. PubMed 36116089 ↗
  • Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2. PubMed 34637140 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03537118
Lead sponsor
Population Health Research Institute
Responsible party
Sponsor
First posted
May 25, 2018
Start date
Jun 20, 2018
Primary completion
May 30, 2022
Completion
Jul 15, 2022
Last update
Aug 12, 2022

Study contacts

Sanjit S Jolly, MD
principal investigator · Population Health Research Institute
Tej Sheth, MD
principal investigator · Population Health Research Institute
Jose Winter, MD
principal investigator · Population Health Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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