Clinical trial NCT04726124: MicrOwave and laSer ablaTion Study (MOST Study)
Official title: A Prospective, Multicenter, Randomized, Controlled Clinical Trial to Validate the Safety and Efficacy of Microwave Versus Laser Ablation of the Great Saphenous Vein in Patients With Varicose Veins
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins of Lower Limb
Keywords: endovenous microwave therapy（EMT）
endovenous laser treatment（EVLT）
great saphenous vein
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities

Detailed description: A prospective, multicenter, randomized, controlled clinical trial to validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older, not older than 80 years, male or female
2. Patients clinically diagnosed as primary great saphenous vein insufficiency with reflux lasting \> 0.5 seconds on duplex ultrasound
3. Patients with CEAP grade C2-C6
4. Patients who voluntarily participate in this trial, understand all the risks and benefits described in the informed consent document, and sign the written informed consent form

Exclusion Criteria:

1. Patients with diameter of target lesion vein \< 2 mm or \> 15 mm
2. Patients with previous surgical treatment on the target lesion or patients with acute thrombosis
3. Patients with deep vein thrombosis and superficial vein thrombosis
4. Patients with acute systemic infectious diseases
5. Patients with severe liver and kidney dysfunction (ALT \> 3 times the upper limit of normal value; creatinine \> 225 umol /L)
6. Patients with known uncorrectable bleeding or severe coagulopathy
7. Patients with anesthesia contraindications
8. Patients with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and diabetes mellitus (fasting glucose ≥ 10.0 mmol / L)
9. Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, KT syndrome (Klippel-Trenaunay syndrome), arteriovenous fistula, etc.
10. Patients with other diseases that may cause difficulty in conducting the trial or evaluation, such as mental illness, AIDS, malignant tumors, liver disease, cardiac insufficiency, etc. or patients whose life expectancy is less than 1 year
11. Pregnant, lactating women, or those planning on becoming pregnant during the trial
12. Patients who have participated in clinical trials of other drugs or medical devices in the past 3 months
13. Patients considered unsuitable for inclusion by investigators for other reasons

Primary outcomes:
measure: the complete closure rate of great saphenous vein at 6 months after surgery
timeFrame: 6 months after surgery
Secondary outcomes:
measure: the complete closure rate of great saphenous vein at 12 months after surgery
timeFrame: 12 months after surgery
measure: surgical success rate
timeFrame: immediately after surgery
measure: device performance evaluation
timeFrame: during or after surgery
measure: changes of venous clinical severity score (VCSS) before and after treatment
timeFrame: screening period, 30days, 3 months, 6months, 12 months after surgery
measure: changes of Aberdeen Varicose Vein Questionnaire (AVVQ) score before and after treatment
timeFrame: screening period, 30 days, 3 months, 6 months, 12 months after surgery
measure: time of surgery
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hosipital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Chang Gung Hospital
name: weiwei Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Wu W, Li Y, Li J, Sun M. Efficacy and safety of endovenous microwave ablation versus laser ablation for great saphenous vein varicosis: study protocol for a multicentre, randomised controlled non-inferiority trial. BMJ Open. 2022 May 25;12(5):e059213. doi: 10.1136/bmjopen-2021-059213.