Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6
The prevalence of severe chronic venous insufficiency (CVI) is significant in the growing octogenarian population. While radiofrequency ablation (RFA) is a standard minimally invasive treatment, robust data on its outcomes and safety profiles specifically in patients aged 80 years and older remain scarce. This study ai
| Condition(s) | Chronic Venous Insufficiency, CVI, Radiofrequency Ablation, Octogenarians(Aged 80 and Over), Cohort Study |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The prevalence of severe chronic venous insufficiency (CVI) is significant in the growing octogenarian population. While radiofrequency ablation (RFA) is a standard minimally invasive treatment, robust data on its outcomes and safety profiles specifically in patients aged 80 years and older remain scarce. This study aims to evaluate the risks and benefits of RFA in this specific, high-risk demographic.This prospective, single-arm, single-center cohort study will enroll 50 patients (initial target sample size) aged ≥80 years with CVI classified as CEAP C3 to C6 and with confirmed great or small saphenous vein reflux. All participants will undergo endovenous RFA under tumescent local anesthesia. The primary outcomes are: 1) the great/small saphenous vein occlusion rate at 6 months, assessed |
| Who can participate | Inclusion Criteria: 1. Age: Aged 80 years or older. 2. 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 3. 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. 4. 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 exclud |
| Ages | 80 Years |
| Sex | All |
| Lead sponsor | Chengdu University of Traditional Chinese Medicine |
| Locations | Chengdu, Sichuan, China |
| Start date | 2025-10-01 |
| NCT ID | NCT07233616 |
| Official listing | https://clinicaltrials.gov/study/NCT07233616 |