N/A
Completed N=33
Vasculaire Compression System Increases Flow Velocity in the Femoral Vein
Source: ClinicalTrials.gov NCT01240330 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcomePrimary: Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline — 18.9 cm/s — p=<0.0001
Summary
The objective of this clinical study was to demonstrate the performance of the Vasculaire Compression System to increase femoral venous peak velocity (PFV) in healthy subjects. This study was a single-arm, open label, prospective, single-center clinical study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline |
18.9 | <0.0001 sig |
| SECONDARY PFV Percent Augmentation |
175.5 | — |
| SECONDARY Subject Comfort |
4.94; 4.94; 5.00 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between 18 years old and 65 years old;
- Capable of and willing to lay supine for approximately one hour;
- Subjects must provide written informed consent
Exclusion Criteria
- History of Deep Vein Thrombosis (DVT) or suspected DVT;
- History of vascular disease, e.g. coronary or peripheral artery disease;
- History of stroke;
- History of pulmonary edema;
- History of congestive heart failure;
- Diabetes mellitus;
- Past or present smoker;
- Surgery or trauma to the right leg within the last six months;
- Open ulcers or wounds on the right leg;
- Pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT01240330). 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.