Registry of the treatment of primary insufficiency of the great saphenous vein with a diameter >/= 12 mm, antero-lateral branches, or great saphenous vein insufficiency below the knee with mechano-chemical endovenous ablation (MOCA)

Registry of the treatment of primary insufficiency of the great saphenous vein with a diameter >/= 12 mm, antero-lateral branches, or great saphenous vein insufficiency below the knee with mechano-chemical endovenous ablation (MOCA) - MOCA-XL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41034

Enrollment

Registered

2014-10-20

Start date

2016-12-20

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dilated veins Varicose veins

Interventions

Treatment with mechano-chemical ablation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Symptomatic varicose veins, C3-C5 2. Ultrasound criteria: a. Diameter supragenual great saphenous vein (GSV) >/= 12 mm , not tortuous; or b. Insufficient antero-lateral branch 18 year en

Exclusion criteria

Exclusion criteria: 1. Patient is not capable to provide informed consent 2. Pregnancy and lactation 3. C6 varicose veins 4. Previous surgery or endovenous ablation at to treated segment 5. Deep venous vein thrombosis in medical history 6. Oral anti-coagulant therapy 7. Contra-indications or allergy for sclerosant 8. Immobilisation 9. Coagulant disorders or increaased risk for thrombo-embolic complications: known coagulant disorders such as hemofilia A, hemofilia B, Von Willebrand disease, Glanzmann disease, factor VII-deficiency, idiopathic thrombo-cytopenic purpura, factor V Leiden disease and deep venous thrombosis or lung emboli in medical history 10. Fontaine III of IV peripheral arterial disease 11. Severe kidney disease: known GFR

Design outcomes

Primary

Measure	Time frame
- Anatomical success (occlusion rate, based on ultrasound) - Clinical success (CEAP, VCSS) - Postoperative complications, especially sensibility disturbances	—

Secondary

Measure	Time frame
- Per-operative pain (VAS-score) - Post-operative pain during first 2 weeks (VAS-score, used pain medication) - Disease specific and general health questionnaire (AVVQ, SF-36) - Time to resume daily activities and work - Intervention duration	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)