Clinical trial NCT02585726: Lake Washington Vascular VenaSeal™ Post-Market Evaluation (WAVES)
Official title: Lake Washington Vascular VenaSeal™ Post-Market Evaluation: WAVES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Reflux
Keywords: Varicose Veins
Great Saphenous Vein
Venous Insufficiency
Lead sponsor: Lake Washington Vascular
Sponsor class: OTHER
Collaborators: name: Syntactx
First posted: 2015-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.
timeFrame: 1 month
Secondary outcomes:
measure: CC of the PTVS, as assessed by duplex ultrasound
timeFrame: 1 week and 3 months after treatment
measure: CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound
timeFrame: 1 month and 3 months after the index procedure
measure: Quality of life as measured by the venous clinical severity scores (rVCSS)
timeFrame: 1 and 3 months after treatment
measure: Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: 1 and 3 months after treatment
measure: Quality of life as measured by the EQ-5D
timeFrame: 1 and 3 months after treatment
measure: Return to normal activities and return to work; day of procedure is day 0
timeFrame: 1 week, 1 month
measure: Need for adjunctive treatment
timeFrame: 3 months
measure: Safety and adverse event for below the knee greater saphenous vein treatment
timeFrame: 1 week, 1 month, 3 months
measure: Safety and adverse events for large diameter TVS defined as veins larger than 8 mm in diameter
timeFrame: 1 week, 1 month, 3 months
measure: Patient satisfaction
timeFrame: 1 week, 1 month, 3 months
measure: CC of TVS, expressed on a per-segment basis
timeFrame: 1 month and 3 months
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Lake Washington Vascular, PLLC
state: Washington
Study officials:
References:
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