VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 20
- 主要终点
- Number of Participants With Complete Closure of the Target Vein at 3 Months
研究概览
简要总结
The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.
详细描述
The purpose of the VeClose study was to demonstrate safety and effectiveness of the VenaSeal SCS as being both 1) non-inferior to RFA therapy in achieving anatomical closure of lower extremity superficial truncal veins in patients with venous reflux through endovascular transcatheter embolization with coaptation of the GSV at 3 months, and 2) superior in the reduction of intraprocedural and post procedural pain and symptoms as compared to treatment with RFA.
The study was designed to demonstrate safety of the VenaSeal SCS by follow-up visits that evaluated, via duplex ultrasound and physical exam, the presence of deep vein thrombosis and/or pulmonary embolus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years and ≤ 70 years of age at the time of screening
- •Reflux in the great saphenous vein (GSV) greater than 0.5 sec reflux
- •One or more of the following symptoms related to the target vein: aching, throbbing, heaviness, fatigue, pruritis, night cramps, restlessness, generalized pain or discomfort, swelling
- •GSV diameter while standing of 3-12 mm throughout the target vein as measured by Duplex ultrasound
- •Clinical, etiology, assessment and pathophysiology (CEAP) classification of C2 (if symptomatic) - C4b
- •Ability to walk unassisted
- •Ability to attend follow-up visits
- •Ability to understand the requirements of the study and to provide informed consent
排除标准
- •Life expectancy < 1 year
- •Active treatment for malignancy other than non-melanoma skin cancer
- •Symptomatic peripheral arterial disease with ankle-brachial index (ABI) <0.89
- •Daily use of narcotic or non-steroidal anti-inflammatory pain medications to control pain associated with GSV reflux
- •Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)
- •Previous or suspected deep vein thrombosis (DVT) or pulmonary embolus (PE)
- •Previous superficial thrombophlebitis in GSV
- •Previous treatment of venous disease in target limb, other than spider vein treatment
- •Known hypercoagulable disorder
- •Conditions which prevent vein treatment with either RFA or VenaSeal SCS
- •Immobilization or inability to ambulate
- •Pregnant prior to enrollment
- •Tortuous GSV, which, in the opinion of the investigator, will limit catheter placement or require more than one primary access site
- •Aneurysm of the target vein with local diameter >12 mm
- •Significant, incompetent, ipsilateral small saphenous, intersaphenous or anterior accessory great saphenous vein(s)
- •Known sensitivity to cyanoacrylate (CA) adhesives
- •Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment
- •Patients who require bilateral treatment during the next 3 months
- •Patients who require additional ipsilateral treatments on the same leg within 3 months following treatment
研究组 & 干预措施
VenaSeal SCS
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA.
干预措施: VenaSeal SCS (Device)
RFA (ClosureFast)
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Heat is applied to the target vein using radiofrequency energy to ablate the target vein. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or RFA.
干预措施: ClosureFast Radiofrequency Ablation (RFA) (Device)
Roll-in (VenaSeal SCS)
Prior to initiation of the randomized cohort at each site, a non-randomized cohort of 2 subjects per clinical site (roll-in phase) were enrolled and treated with VenalSeal SCS with endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc.
干预措施: Roll-in (VenaSeal SCS) (Device)
结局指标
主要结局
Number of Participants With Complete Closure of the Target Vein at 3 Months
时间窗: 3 months
The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
次要结局
- Intraoperative Pain(During the operative procedure, which was an average of 24 minutes for VenaSeal SCS, 19 minutes for RFA, and 31 minutes for Roll-in group.)
- Ecchymosis at Day 3(First follow up visit at day 3)