Trial Outcomes & Findings for Femoral Arterial Access With Ultrasound Trial (NCT NCT00667381)

Results Overview

Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses. Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1014 participants

Primary outcome timeframe

Immediately, during procedure.

Results posted on

2010-11-16

Participant Flow

Between April 2008 and February 2009, 1014 patients presenting for elective or urgent (but not emergent) cardiac or peripheral catheterization were enrolled.

10 patients (6 control, 4 US) were excluded after randomization but before procedure for no longer meeting the inclusion criteria, including cancellation of the procedure, lack of a dual-trained operator, or change in access site. Baseline and procedural data were not recorded in this group, and these were not included in any analysis.

Participant milestones

Participant milestones
Measure	Control The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.	Ultrasound Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
Overall Study STARTED	501	503
Overall Study COMPLETED	501	503
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Femoral Arterial Access With Ultrasound Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=501 Participants The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.	Ultrasound n=503 Participants Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.	Total n=1004 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	255 Participants n=5 Participants	273 Participants n=7 Participants	528 Participants n=5 Participants
Age, Categorical >=65 years	246 Participants n=5 Participants	230 Participants n=7 Participants	476 Participants n=5 Participants
Age Continuous	64.2 years STANDARD_DEVIATION 11.4 • n=5 Participants	63.5 years STANDARD_DEVIATION 12.4 • n=7 Participants	63.8 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants	132 Participants n=7 Participants	267 Participants n=5 Participants
Sex: Female, Male Male	366 Participants n=5 Participants	371 Participants n=7 Participants	737 Participants n=5 Participants
Region of Enrollment United States	501 participants n=5 Participants	503 participants n=7 Participants	1004 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately, during procedure.

Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses. Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers.

Outcome measures

Outcome measures
Measure	Control n=490 Participants The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.	Ultrasound n=499 Participants Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography	408 participants	431 participants

SECONDARY outcome

Timeframe: Immediate

Time was measured from first fluoroscopy of the femoral head (control group), or first application of the ultrasound probe (ultrasound group), until successful sheath insertion. Time was not recorded for 1 control patient, and 1 ultrasound patient, these patients were excluded from this analysis but included for other analyses.

Outcome measures

Outcome measures
Measure	Control n=500 Participants The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.	Ultrasound n=502 Participants Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
Time to Successful Sheath Insertion.	213 seconds Standard Deviation 194	185 seconds Standard Deviation 175

SECONDARY outcome

Timeframe: Immediate

Number of patients with any femoral venipunctures where an insertion was not intended, i.e. excluding patients with planned right heart catheterization. Multiple accidental venipunctures were not double counted. Number of attempts and venipunctures were not recorded in 1 control and 1 ultrasound patient, so the denominator is 500 control patients and 502 ultrasound patients.

Outcome measures

Outcome measures
Measure	Control n=500 Participants The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.	Ultrasound n=502 Participants Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
Number of Patients With Accidental Femoral Venipunctures.	79 participants	12 participants

SECONDARY outcome

Timeframe: Immediate and up to 1 month after procedure.

Vascular complications were defined as vessel thrombosis, dissection, blood transfusion, hematoma \> 5cm diameter, unexplained bleeding with a drop in Hgb \>4 g/dL, or access site bleeding with drop in Hgb \>3 g/dL. Outcome was assessed by chart review, and clinical or telephone followup at 30 days. Medical records were adjudicated by a blinded independent review committee.

Outcome measures

Outcome measures
Measure	Control n=501 Participants The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.	Ultrasound n=503 Participants Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
Number of Participants With Vascular Complications	17 participants	7 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At angiogram analysis

Patients found to have femoral artery bifurcations occurring over the femoral head were prospectively defined as having a high femoral bifurcation. This subgroup was prespecified for analysis during the trial designed, as it was suspected that operators would have particular difficulty inserting the sheath accurately in this population.

Outcome measures

Outcome measures
Measure	Control n=159 Participants The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.	Ultrasound n=149 Participants Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations	111 participants	123 participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Ultrasound

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=501 participants at risk The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.	Ultrasound n=503 participants at risk Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
Vascular disorders Any vascular complication	3.4% 17/501 • Number of events 17	1.4% 7/503 • Number of events 7

Additional Information

Arnold Seto

University of California, Irvine

Phone: 714-456-6699

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place