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

Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over: A Prospective Single-Arm Cohort Study

This will try radiofrequency ablation in people aged 80 and older with severe chronic venous insufficiency to see if it safely closes the leaking saphenous veins and improves symptoms and quality of life.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 80 Years and up
• Sex: All
• Sponsor: Chengdu University of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07233616 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ambulatory adults aged 80 or older with symptomatic CEAP C3–C6 disease and duplex-confirmed reflux of the great or small saphenous vein who can provide informed consent are ideal candidates.

Not a fit: Patients who are non-ambulatory, have active deep vein thrombosis or acute superficial thrombophlebitis of the target vein, or cannot tolerate local anesthesia are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the procedure could offer a minimally invasive option that safely closes refluxing veins and improves symptoms and wound healing in octogenarians.

How similar studies have performed: Endovenous radiofrequency ablation has good closure and symptom-improvement data in general adult populations, but high-quality outcome data specifically for patients aged 80 and over are limited.

Eligibility criteria

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 this trial is running

Chengdu, Sichuan

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

Study contacts

• Study coordinator: Chunshui He Doctor

Conditions Chronic Venous Insufficiency, CVI; Radiofrequency Ablation; Octogenarians; Cohort Study