A multicenter, open-label, non-inferiority, randomized controlled trial comparing mechanochemical endovenous ablation using Flebogrif with endovenous laser ablation in the treatment of primary great saphenous vein incompetence.

Recruiting

• Conditions: spider veins; Varicose veins; 10057165

• Registration Number: NL-OMON54246
• Lead Sponsor: oordwest Ziekenhuisgroep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 310

Inclusion Criteria

1. Age 18-80 years
2. Unilateral symptomatic primary GSV and SFJ incompetence
3. GSV diameter >= 4 or <= 12 mm
4. GSV treatment length >= 15 cm

Exclusion Criteria

1. Bilateral endovenous thermal/MOCA treatment of the GSV
2. Simultaneous ipsilateral endovenous thermal-/MOCA treatment of additional
veins
3. C6 varicose veins
4. Previous ipsilateral GSV or AASV treatment
5. Superficial thrombophlebitis or deep venous thrombosis in the last 6 months
6. Occlusion of deep venous system
7. Coagulation disorders or increased risk of thromboembolism
8. Direct oral anticoagulants or vitamin K antagonists
9. Pregnancy or lactation
10. Immobilization
11. Cognitive impairment or language barrier
12. Allergy or contraindication to Polidocanol
13. Severe renal or liver insufficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes is anatomical succes at 12 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are: intraprocedural pain, technical success, operation<br /><br>time, postoperative pain, anatomical succes at 1, 6, 12, 24 and 60 month(s),<br /><br>safety, complications, clinical success, quality of life, aesthetic result,<br /><br>re-interventions and neo-reflux/vascularization.</p><br>