N/A
N=1,004
Femoral Arterial Access With Ultrasound Trial
Vascular Access Complications · Cardiac Catheterization · Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00667381 ↗Enrolled (actual)
1,004
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: Primary: Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography — 408; 431 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography |
408; 431 | — |
| SECONDARY Time to Successful Sheath Insertion. |
213; 185 | — |
| SECONDARY Number of Patients With Accidental Femoral Venipunctures. |
79; 12 | — |
| SECONDARY Number of Participants With Vascular Complications |
17; 7 | — |
Summary
This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography.
Eligibility Criteria
Inclusion Criteria
- Adults age 18 and over
- Patients undergoing left heart catheterization or peripheral arterial angiography from the retrograde femoral approach
- Willingness and ability to sign consent form
- Scheduled to have procedure performed by operator trained in the ultrasound technique
Exclusion Criteria
- Access from a site other than the common femoral artery
- Nonpalpable femoral pulses
- Creatinine > 3.0 mg/dl, unless already on dialysis
- Prisoners
- Pregnant women
- Unable or refusal to sign consent form
- Patients undergoing emergent cardiac catheterization for ST segment elevation myocardial infarction or unstable acute coronary syndrome
- Equipment unavailable
Data sourced from ClinicalTrials.gov (NCT00667381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.