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

Inclusion criteria

• Age: Aged 80 years or older.
• Clinical Diagnosis: Symptomatic chronic venous insufficiency of the lower extremity, with the highest clinical class (CEAP classification) being one of the following:

• C3: Venous edema
• C4a: Pigmentation or eczema
• C4b: Lipodermatosclerosis or atrophie blanche
• C5: Healed venous ulcer
• C6: Active venous ulcer
• Confirmed Reflux: Color duplex ultrasound examination confirming reflux (reflux time > 0.5 seconds) in the great saphenous vein (GSV) and/or small saphenous vein (SSV) of the target limb.
• Informed Consent: The patient or their legally authorized representative is able to understand and voluntarily provides written informed consent.

Exclusion criteria

• Participants who meet any of the following criteria will be excluded from the study:

• Mobility: Non-ambulatory or bedridden.
• Thrombosis: Presence of acute superficial thrombophlebitis of the target vein, or deep vein thrombosis (DVT) in the target limb.
• Arterial Disease: Significant peripheral arterial disease, defined as an ankle-brachial index (ABI) < 0.8 in the target limb.
• Coagulopathy: Uncorrectable coagulation disorder.
• Allergy: Known severe allergy to local anesthetics (e.g., lidocaine) or relevant device materials.
• Cognition & Compliance: Severe cognitive impairment or psychiatric illness that, in the investigator's judgment, precludes adequate understanding and cooperation for the study procedures and follow-up.
• Life Expectancy: Life expectancy of less than 1 year due to other comorbid conditions (e.g., terminal malignancy).
• General Unsuitability: Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.