Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures
UNIVERSAL
1 other identifier
interventional
621
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 25, 2018
CompletedStudy Start
First participant enrolled
June 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedAugust 12, 2022
August 1, 2022
3.9 years
May 15, 2018
August 9, 2022
Conditions
Outcome Measures
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
up to 30 days post-procedure
Study Arms (2)
Fluoroscopic + Ultrasound Guidance
EXPERIMENTALFluoroscopic Guidance Alone
NO INTERVENTIONInterventions
Fluoroscopic Guidance Alone
Eligibility Criteria
You may qualify if:
- Patient referred for coronary angiography or percutaneous coronary intervention (PCI) in whom femoral access is planned.
- Planned femoral access
You may not qualify if:
- Age ≤ 18 years
- STEMI
- Absence of palpable femoral pulse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hamilton Health Sciences
Hamilton, Ontario, L8L2X2, Canada
Related Publications (3)
Strauss SA, Ma GW, Seo C, Siracuse JJ, Madassery S, Truesdell AG, Pereira K, Korngold EC, Kayssi A. Ultrasound-guided versus anatomic landmark-guided percutaneous femoral artery access. Cochrane Database Syst Rev. 2025 Mar 28;3(3):CD014594. doi: 10.1002/14651858.CD014594.pub2.
PMID: 40152297DERIVEDJolly 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.
PMID: 36116089DERIVEDFlumignan 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.
PMID: 34637140DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjit S Jolly, MD
Population Health Research Institute
- PRINCIPAL INVESTIGATOR
Tej Sheth, MD
Population Health Research Institute
- PRINCIPAL INVESTIGATOR
Jose Winter, MD
Population Health Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
May 25, 2018
Study Start
June 20, 2018
Primary Completion
May 30, 2022
Study Completion
July 15, 2022
Last Updated
August 12, 2022
Record last verified: 2022-08