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

Lake Washington Vascular50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Reflux

Interventions

SP-402 VenaSeal™ Closure SystemDEVICE

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..

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Lake Washington Vascular, PLLC

Bellevue, Washington, United States

Outcomes

Primary Outcomes

Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.

CC of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.

Time frame: 1 month

Secondary Outcomes

CC of the PTVS, as assessed by duplex ultrasound

Time frame: 1 week and 3 months after treatment

CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound

Time frame: 1 month and 3 months after the index procedure

Quality of life as measured by the venous clinical severity scores (rVCSS)

Time frame: 1 and 3 months after treatment

Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ)

Time frame: 1 and 3 months after treatment

Quality of life as measured by the EQ-5D

Time frame: 1 and 3 months after treatment

Return to normal activities and return to work; day of procedure is day 0

Time frame: 1 week, 1 month

Need for adjunctive treatment

Measured in case report form (yes or no, and if yes, the Investigator will specify what the adjunctive measure is).

Time frame: 3 months

Safety and adverse event for below the knee greater saphenous vein treatment

Time frame: 1 week, 1 month, 3 months

Data from ClinicalTrials.gov

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