Lake Washington Vascular VenaSeal™ Post-Market Evaluation

• Conditions: Venous Reflux; Varicose Veins

• Registration Number: NCT04146168
• Lead Sponsor: Lake Washington Vascular

Brief Summary

New-WAVES Study seeks to expand understanding/results from prior study (NCT02585726). Assessing both clinical outcomes and patient satisfaction after treatment with Venaseal/Cyanoacrylate Adhesive Closure System

Detailed Description

New WAVES is an investigator initiated protocol that will assess clinical outcomes and patient satisfaction after treatment with VenaSeal(TM)/ Cyanoacrylate Adhesive Closure System 3 years post-treatment. All patients treated from a multi-provider practice, whom meet protocol inclusion criteria, will be invited to consider participation in this study.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-30
• Study First Posted: 2019-10-31
• Last Update Posted: 2019-10-31
• Study Start: 2019-11
• Primary Completion: 2020-01
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Age ≥18 years; 2. Treatment of the great, small or accessory saphenous vein or any combination of saphenous veins with the Venaseal Closure System; 3. Treatment occurred at least 30 months prior to study; 4. Ability to understand the requirements of the study and to provide informed consent.

Exclusion Criteria

1. Subsequent treatment (such as laser or radiofrequency ablation) of venous disease in targeted vein segment after Venaseal closure; 2. Patients in whom index procedure information is unavailable; 3. Patients unwilling to undergo ultrasound evaluation and clinical examination of the previously treated limb; 4. Limbs that were treated in the VeClose trial (patients who participated in VeClose and later had contralateral limb treatment will be included).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Closure of Target Vein(s) at 3 years after index treatment	3 years post treatment	Complete closure is defined as Doppler Ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm.

Secondary Outcome Measures

Name	Time	Method
Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire	3 years post treatment	Assessed via EQ-5D Questionnaire. The EQ-5D is a short generic quality of life survey that is commonly used outside of the United States for health technology assessments. The "health state today" question provides an overall assessment along a 20 cm visual analog scale (VAS) with a range from 0 ("worst imaginable health state") to 100 ("best imaginable health state").
Need for adjunctive treatments	3 years post treatment	Either at the index procedure or at any point following the index procedure
Health care utilization	3 years post treatment	Via chart review and patient questionnaire
Venous disease severity assessed via Venous Clinical Severity Score	3 years post treatment	Assessed via the revised Venous Clinical Severity Score (rVCSS). The rVCSS is an Investigator assessment of the severity of venous reflux disease, assessing signs and symptoms such as pain, varicose veins, venous edema, skin pigmentation, induration, and inflammation.
Clinical Severity via Varicose Vein Questionnaire (AVVQ)	3 years post treatment	Assessed via Aberdeen Varicose Vein Questionnaire (AVVQ) is a disease specific 13 item questionnaire is used to assess the impact of varicose veins on the quality of life, such as pain caused by varicose veins, and the need to take pain medication.

Trial Locations

Locations (1)

Lake Washington Vascular; 🇺🇸 Kirkland, Washington, United States