Lake Washington Vascular VenaSeal™ Post-Market Evaluation (WAVES)

Lake Washington Vascular

Status

Completed

Conditions

Venous Reflux

Treatments

Device: SP-402 VenaSeal™ Closure System

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT02585726

2015-01

Details and patient eligibility

About

The VenaSeal Closure system offers an outpatient treatment option for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Reflux in at least one target vein;
One or more of the following symptoms related to a TV: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling;
CEAP classification of C2 (if symptomatic) through C5;

Key Exclusion Criteria:

Current, regular use of systemic anticoagulation;
Previous or suspected deep vein thrombosis or pulmonary embolus, or active acute superficial thrombophlebitis, or thrombophlebitis migrans;
Previous treatment such as laser or radiofrequency ablation of venous disease in targeted vein segment;
Known hypercoagulable disorder;
Pregnant or breast feeding at enrollment;
Known sensitivity to cyanoacrylate adhesives;
Venous treatment in the contralateral limb within the last 30 days, or who require contralateral treatment within three months;
Planned to undergo additional ipsilateral treatments on the same leg within 3 months following treatment.