Study design of the VenaSeal Spectrum Program: Two randomized controlled trials and one single-arm prospective study of a cyanoacrylate closure system to treat early to advanced chronic venous disease

Abstract

Background/ObjectiveChronic venous disease (CVD) affects >25% of adults in developed countries. It is usually a progressive disease; if left untreated, can lead to advanced disease such as venous ulceration. The VenaSeal Spectrum Program compares the VenaSeal closure system (VenaSeal) to the global standards of care for CVD: endothermal ablation and surgical stripping. It also investigates VenaSeal's usefulness for patients with venous leg ulcers (VLUs). A key component of this clinical program was to measure and quantify patient satisfaction with treatments related to discomfort, healing time, and effectiveness, which often has been overlooked in CVD research. This article describes the rationale and design of the VenaSeal Spectrum Program for patients with CVD. MethodsVenaSeal Spectrum is a prospective, postmarket, clinical trial program reporting outcomes from the periprocedural period through 5 years after treatment with VenaSeal. VenaSeal Spectrum has enrolled 506 participants at 32 sites in 10 countries requiring treatment for symptomatic Clinical, Etiological, Anatomical, and Pathophysiological Classification (CEAP) 2-6 CVD involving the truncal saphenous vein(s). The program is composed of three studies. Two randomized controlled trials compare VenaSeal ablation with either surgical stripping or endovenous thermal ablation in patients with symptomatic CEAP 2-5 disease. A single-arm prospective study investigates participants with active VLUs (CEAP 6) treated with VenaSeal. The unique primary end points for both randomized trials include both periprocedural and postprocedural patient treatment satisfaction measured by a new questionnaire (VenousTSQ) at 30 days post procedure and elimination of clinically relevant superficial truncal reflux in the target vein at index procedure. The primary end point for the VLU study is time to ulcer healing through 12 months. Secondary end points, which are more familiar to clinicians in this disease space, include time to return to work, complication rates, patient-reported outcome measures, and closure rates. ConclusionsVenaSeal Spectrum is a rigorously designed clinical study program with a large study population and unique patient-centric end points after treatment with VenaSeal for early to advanced symptomatic CVD. The studies report on the safety, effectiveness, and patient experience outcomes including two new primary end points assessing the specific needs of patients with venous insufficiency from the periprocedural period through 5-year follow-up.