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

Recruitingn/aAges 80 Years - anyAllChengdu University of Traditional Chinese Medicine
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ80 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 by duplex ultrasonography, and 2) the change in disease-specific quality of life from baseline to 6

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๐Ÿ“‹ Eligibility rules (as published)
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 excluded from the study: 1. Mobility: Non-ambulatory or bedridden. 2. Thrombosis: Presence of acute superficial thrombophlebitis of the target vein, or deep vein thrombosis (DVT) in the target limb. 3. Arterial Disease: Significant peripheral arterial disease, defined as an ankle-brachial index (ABI) \< 0.8 in the target limb. 4. Coagulopathy: Uncorrectable coagulation disorder. 5. Allergy: Known severe allergy to local anesthetics (e.g., lidocaine) or relevant device materials. 6. 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. 7. Life Expectancy: Life expectancy of less than 1 year due to other comorbid conditions (e.g., terminal malignancy). 8. General Unsuitability: Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
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What it tests

  • Endovenous Radiofrequency Ablation
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Where

1 site
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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