Greater Saphenous Vein Injury Clinical Trial
— MARADONAOfficial title:
Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial
| Verified date | February 2021 |
| Source | Rijnstate Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.
| Status | Completed |
| Enrollment | 213 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Insufficiency of the GSV - Signed informed consent - Patient willing to participate in follow-up scheme - Age > 18 years - Ultrasound criteria for endovenous treatment have been met: - Diameter GSV between 3-12 mm - No thrombus in the to be treated segment of the GSV Exclusion Criteria: - Patient not able to give informed consent - Patient unable to present at follow-up visits - Other treatment is more suitable - Pregnancy and breast feeding - Known allergy/ contra-indication for sclerotherapy - Previous ipsilateral surgical treatment of varicose veins - Deep venous thrombosis or lung emboli in medical history - Anticoagulant therapy - C5-C6 varices - Immobilization - Fontaine II or IV peripheral arterial disease - Severe kidney function decline (GFS < 30 mL/min) - Coagulation disorder or increased risk for thrombo-embolic complications(hemofilie A or B, v. Willebrand disease, Glanzmann disease, Factor VII-deficiency, idiopatic thrombocytopenic purpura, Factor V Leiden) - Liver diseases accompanied by changes in blood coagulation, livver cirrhosis |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | BovenIJ Hospital | Amsterdam | |
| Netherlands | OLVG | Amsterdam | |
| Netherlands | Rijnstate Hospital | Arnhem | Gelderland |
| Netherlands | UMCG | Groningen | |
| Netherlands | St. Antonius Hospital | Nieuwegein |
| Lead Sponsor | Collaborator |
|---|---|
| Rijnstate Hospital | BovenIJ Hospital, OLVG, St. Antonius Hospital |
Netherlands,
Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein(®) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303. doi: 10.1016/j.ejvs.2012.12.004. Epub 2013 Jan 9. — View Citation
van Eekeren RR, Boersma D, de Vries JP, Reijnen MM. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177. Dutch. — View Citation
van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011 Jun;18(3):328-34. doi: 10.1583/11-3394.1. — View Citation
van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013 Feb;57(2):445-50. doi: 10.1016/j.jvs.2012.07.049. Epub 2012 Nov 8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Recovery time | Time until daily activities and or work can be resumed (measured in days) | 30 days | |
| Primary | Occlusion rate | Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success) | up to 5 years | |
| Secondary | Per-procedural pain score | Pain during the procedure will be compared between treatments using the VAS score | two weeks | |
| Secondary | Complications | Complication at day 30 will be compared between treatments. | 30 days | |
| Secondary | Procedure duration | The duration of the procedures will be compared | 30 days | |
| Secondary | Costs of both treatments | The total costs of both treatments will be compared | 1 year | |
| Secondary | Health status | Using the RAND 36-Item short From Health Survey (SF36) the general health status will be compared between treatments at various time points as specified by the protocol. | 1 year, 5 years | |
| Secondary | Post procedural pain score | Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score | two weeks | |
| Secondary | Disease related quality of life | Using the Aberdeen Varicose Vein Questionnaire (AVVQ)the disease related quality of life will be compared between treatments at various time points as specified by the protocol. | 1 year, 5 years |