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N/A Completed N=1,004 Randomized Single-blind Treatment

Femoral Arterial Access With Ultrasound Trial

Vascular Access Complications · Cardiac Catheterization · Peripheral vascular disease
Source: ClinicalTrials.gov NCT00667381 ↗
Enrolled (actual)
1,004
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcomePrimary: Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography — 408; 431 participants

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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