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

Objective Chronic venous disease affects over 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 chronic venous disease: endothermal ablation and surgical stripping. It also investigates VenaSeal's utility for patients with venous leg ulcers. A key component of this clinical program is to measure and quantify patient satisfaction of treatments related to discomfort, healing time, and effectiveness, which often has been overlooked in chronic venous disease research. This paper describes the rationale and design of the VenaSeal Spectrum Program for patients with chronic venous disease. Methods VenaSeal Spectrum is a prospective, post-market, clinical trial program reporting outcomes from the peri-procedural period through 5 years following 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 chronic venous disease 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 venous leg ulcers (VLUs; CEAP 6) treated with VenaSeal. The unique primary endpoints for both randomized trials include both peri- and post-procedural 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 endpoint for the VLU study is time to ulcer healing through 12 months. Secondary endpoints, 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. Conclusions VenaSeal Spectrum is a rigorously designed clinical study program with a large study population and unique patient-centric endpoints after treatment with VenaSeal for early to advanced symptomatic chronic venous disease. The studies will report safety, effectiveness and patient experience outcomes including two new primary endpoints assessing the specific needs of patients with venous insufficiency from the peri-procedural period through 5-year follow-up.