Evaluating Risks and Benefits of Radiofrequency Ablation for Severe Chronic Venous Insufficiency in Patients Aged 80 and Older

What this Trial Is About

Researchers are evaluating the risks and benefits of radiofrequency ablation RFA for treating severe chronic venous insufficiency CVI in patients aged 80 years and older. This study focuses on a vulnerable and growing population with CVI classified as CEAP C3 to C6 and confirmed reflux in the great or small saphenous veins. The purpose is to gather detailed safety and outcome data specific to this high-risk age group to inform clinical decisions and treatment guidelines. All participants will undergo endovenous RFA using the ClosureFast system or an equivalent device. The treatment is delivered under local tumescent anesthesia with ultrasound guidance to ablate the target saphenous vein. After the procedure, compression bandaging and Class II compression stockings will be used. This is a single-arm, prospective cohort study enrolling 50 patients, with follow-up assessments at 1, 3, and 6 months after the procedure. Participants will be monitored through duplex ultrasonography to measure vein occlusion rates and will complete quality of life questionnaires such as the Aberdeen Varicose Vein Questionnaire AVVQ and the Venous Clinical Severity Score VCSS. Safety outcomes including complications like deep vein thrombosis and skin burns will be tracked within 30 days. The main outcomes are evaluated at 6 months, and the study provides a comprehensive profile of both technical success and patient-reported improvements over half a year.

Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over