Vasculaire Compression System Increases Flow Velocity in the Femoral Vein

Not Applicable

Completed

Conditions: Venous Thrombosis

Registration Number: NCT01240330

Lead Sponsor: Venous Health Systems, Inc.

Brief 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.

Detailed Description: Venous thromboembolism, e.g. deep vein thrombosis (DVT) and pulmonary embolism, occurs in approximately one in 1,000 persons in the United States annually and results in more than 250,000 hospital admissions annually in the United States. Intermittent pneumatic compression (IPC), which prevents stasis in the lower limbs, has been shown to be a safe and effective method of prophylaxis of DVT in studies comparing the incidence of DVT and pulmonary embolism with and without IPC. IPC devices decrease venous stasis by augmenting the venous blood flow in the lower extremities. Studies have suggested that an important indicator of the effectiveness of an IPC device in preventing DVT is the peak femoral venous velocity augmentation during the compression phase as compared with the decompression phase of the device.

IPC devices produced in the early 1980s and 1990s were cumbersome, noisy and required external power sources, making them suitable only for non-ambulatory patients. Furthermore, these devices have been associated with poor compliance in trauma patients in a hospital setting, and the poor compliance was associated with a higher rate of DVT.

The aim of this study is to test the hemodynamic performance of a new portable IPC device, the Venous Health Systems' Vasculaire Compression System. This new device is designed to provide patient comfort and convenience of use while providing similar improvement in venous blood flow when compared with existing IPC devices.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline	3 measurements/10 min. therapy	The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.

Secondary Outcome Measures

Name	Time	Method
PFV Percent Augmentation	3 measurements/10 minute therapy	Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation.
Subject Comfort	10 min therapy	Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.