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

Not Applicable

Completed

• Conditions: Venous Reflux
• Interventions: Device: SP-402 VenaSeal™ Closure System

• Registration Number: NCT02585726
• Lead Sponsor: Lake Washington Vascular

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Historical Control with Propensity Analysis	SP-402 VenaSeal™ Closure System	-
VenaSeal Treatment Arm	SP-402 VenaSeal™ Closure System	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of life as measured by the venous clinical severity scores (rVCSS)	1 and 3 months after treatment
Return to normal activities and return to work; day of procedure is day 0	1 week, 1 month
Safety and adverse event for below the knee greater saphenous vein treatment	1 week, 1 month, 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).
CC of the PTVS, as assessed by duplex ultrasound	1 week 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
CC of TVS, expressed on a per-segment basis	1 month and 3 months
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
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.

Trial Locations

Locations (1)

Lake Washington Vascular, PLLC; 🇺🇸 Bellevue, Washington, United States