Radiofrequency ablation for severe leg vein disease in people 80 and older

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, single-center cohort enrolling about 50 patients aged 80 years or older with CEAP class C3–C6 chronic venous insufficiency and duplex-proven great or small saphenous vein reflux. All participants undergo endovenous radiofrequency ablation performed under tumescent local anesthesia, with clinical follow-up and duplex ultrasound. The co-primary outcomes are vein occlusion rate at 6 months by duplex ultrasonography and change in disease-specific quality of life measured by the Aberdeen Varicose Vein Questionnaire (AVVQ) from baseline to 6 months. Secondary outcomes include procedure-related complications, ulcer healing in affected patients, symptom scores, and any recanalization or need for additional interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital of Chengdu University of Traditional Chinese Medicine
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Chunshui He Doctor
• Email: Chunshuihe@msn.com
• Phone: 18981885601

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.