Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins (EMINENCE)
Vascular Diseases, Peripheral, Venous Insufficiency of Leg, Varicose Veins of Lower Limb
About this trial
This is an interventional treatment trial for Vascular Diseases, Peripheral focused on measuring microwave ablation, varicose veins, traditional treatment
Eligibility Criteria
Inclusion Criteria:
- Age >18 years, and <90 years ,and able to understand the requirements of the study and provide informed consent and accept the exams and follow-up.
C2 - C5 varicose veins / CVI Symptomatic primary GSV, SSV or AASV incompetence, with reflux >0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness,fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling.
Patients who has GSV, SSV AASV diameters of 3mm to 12mm in the standing postition.
Only one limb of each patient was included in the study.
Exclusion Criteria:
- Current DVT or history of DVT. Recurrent varicose veins. Pregnant patients. Arterial disease (ABPI <0.8). Patients who are unwilling to participate this test. Inability or unwillingness to complete questionnaires. Adverse reaction to sclerosant or cyanoacrylate. GSV, SSV or AASV severely tortuous. Infectious disease. Life expectancy < 1 year. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin). Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease.
The investigators determined that intravenous therapy was not appropriate.
Sites / Locations
- Hospital of Chengdu University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Experimental
Microwave ablations
A total of 50 patients with varicose veins of lower extremities treated with microwave ablation catheter were selected to observe their annual venous closure rate and postoperative adverse reactions.