Clinical trial NCT01936168: MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins
Official title: Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Greater Saphenous Vein Injury
Keywords: GSV
Primary Varicose Veins
Great Saphenous Vein
Treatment
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: St. Antonius Hospital
name: OLVG
name: BovenIJ Hospital
First posted: 2013-09-05
Enrollment: 213
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Occlusion rate
timeFrame: up to 5 years
Secondary outcomes:
measure: Per-procedural pain score
timeFrame: two weeks
measure: Complications
timeFrame: 30 days
measure: Procedure duration
timeFrame: 30 days
measure: Costs of both treatments
timeFrame: 1 year
measure: Health status
timeFrame: 1 year, 5 years
measure: Post procedural pain score
timeFrame: two weeks
measure: Disease related quality of life
timeFrame: 1 year, 5 years
Other outcomes:
measure: Recovery time
timeFrame: 30 days
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Amsterdam
country: Netherlands
facility: BovenIJ Hospital
city: Amsterdam
country: Netherlands
facility: OLVG
city: Groningen
country: Netherlands
facility: UMCG
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: Rijnstate Hospital Arnhem
name: MMPJ Reijnen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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((R)) 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.
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.
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.
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.
citation: Holewijn S, van Eekeren RRJP, Vahl A, de Vries JPPM, Reijnen MMPJ; MARADONA study group. Two-year results of a multicenter randomized controlled trial comparing Mechanochemical endovenous Ablation to RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial). J Vasc Surg Venous Lymphat Disord. 2019 May;7(3):364-374. doi: 10.1016/j.jvsv.2018.12.014.
citation: van Eekeren RR, Boersma D, Holewijn S, Vahl A, de Vries JP, Zeebregts CJ, Reijnen MM. Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial. Trials. 2014 Apr 11;15:121. doi: 10.1186/1745-6215-15-121.