Efficacy and Safety of ScleroSafe Catheter-directed Sclerotherapy for Varicose Veins: A Prospective Observational Study

Background: Catheter-directed sclerotherapy (CDS) using the ScleroSafe system offers a minimally invasive alternative for treating primary varicose veins caused by superficial venous reflux. Objective: To assess the short-term efficacy and safety of ScleroSafe-based sclerotherapy in achieving complete vein occlusion and symptom relief. Materials and Methods: Thirty patients with CEAP C2–C5 primary varicose veins underwent ScleroSafe-guided sclerotherapy of the great and/or small saphenous veins (SSVs). Technical success was defined as successful cannulation, catheter advancement to the junction, and uniform sclerosant delivery with immediate vein wall contact confirmed on ultrasound. Results: Technical success was achieved in all patients (100%). At day 30, the vein occlusion rate was 95%, and at day 90, 92%. The most common treated vein was the SSV (60%). Immediate symptom relief was reported in leg heaviness (80%) and pain (65%). No cases of deep vein thrombosis, skin necrosis, or new pigmentation occurred. Conclusion: ScleroSafe CDS achieved high early closure rates and significant symptom improvement, demonstrating it as a safe, effective, and reproducible nonthermal alternative for managing superficial venous reflux.