Venous Reflux
Conditions
Keywords
Varicose Veins, Great Saphenous Vein, Venous Insufficiency
Brief summary
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).
Interventions
DEVICESP-402 VenaSeal™ Closure System
A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..
Sponsors
Syntactx
Lake Washington Vascular
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure. | 1 month | CC of the PTVS as assessed by duplex ultrasound 1 month after the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound | 1 month and 3 months after the index procedure | — |
| Quality of life as measured by the venous clinical severity scores (rVCSS) | 1 and 3 months after treatment | — |
| Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ) | 1 and 3 months after treatment | — |
| Quality of life as measured by the EQ-5D | 1 and 3 months after treatment | — |
| Return to normal activities and return to work; day of procedure is day 0 | 1 week, 1 month | — |
| CC of the PTVS, as assessed by duplex ultrasound | 1 week and 3 months after treatment | — |
| Safety and adverse event for below the knee greater saphenous vein treatment | 1 week, 1 month, 3 months | — |
| Safety and adverse events for large diameter TVS defined as veins larger than 8 mm in diameter | 1 week, 1 month, 3 months | — |
| Patient satisfaction | 1 week, 1 month, 3 months | At selected visits, the subject will complete a brief questionnaire rating satisfaction with treatment provided and whether the subject would undergo the treatment again. |
| CC of TVS, expressed on a per-segment basis | 1 month and 3 months | — |
| Need for adjunctive treatment | 3 months | Measured in case report form (yes or no, and if yes, the Investigator will specify what the adjunctive measure is). |
Countries
United States
Outcome results
None listed