Clinical and Patient-Centered Outcomes Three Years After Venaseal Treatment: Lake Washington Vascular VenaSeal Post Market Evaluation
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Complete Closure of Target Vein(s) at 3 years after index treatment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Treatment of the great, small or accessory saphenous vein or any combination of saphenous veins with the Venaseal Closure System;
- •Treatment occurred at least 30 months prior to study;
- •Ability to understand the requirements of the study and to provide informed consent.
排除标准
- •Subsequent treatment (such as laser or radiofrequency ablation) of venous disease in targeted vein segment after Venaseal closure;
- •Patients in whom index procedure information is unavailable;
- •Patients unwilling to undergo ultrasound evaluation and clinical examination of the previously treated limb;
- •Limbs that were treated in the VeClose trial (patients who participated in VeClose and later had contralateral limb treatment will be included).
结局指标
主要结局
Complete Closure of Target Vein(s) at 3 years after index treatment
时间窗: 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.
次要结局
- Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire(3 years post treatment)
- Need for adjunctive treatments(3 years post treatment)
- Health care utilization(3 years post treatment)
- Venous disease severity assessed via Venous Clinical Severity Score(3 years post treatment)
- Clinical Severity via Varicose Vein Questionnaire (AVVQ)(3 years post treatment)