Lake Washington Vascular VenaSeal™ Post-Market Evaluation

Lake Washington Vascular124 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

124

Conditions

Varicose Veins Venous Reflux

Interventions

UltrasoundDIAGNOSTIC_TEST

Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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). \-

Locations (3)

Lake Washington Vascular

Bellevue, Washington, United States

RECRUITING

Lake Washington Vascular

Issaquah, Washington, United States

RECRUITING

Lake Washington Vascular

Kirkland, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

Complete Closure of Target Vein(s) at 3 years after index 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.