MOCA-XL
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)
Sponsor study identifier
observational
45
1 country
1
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2022
Actual (reported)Study Completion
April 2022
Actual (reported)The goal of this registry study is to provide insight in the safety and efficacy of treatment with MOCA for primary insufficiency of the GSV with a diameter \>/=12mm, insufficient antero-lateral branches and insufficiency of the GSV below the knee.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 19, 2015
Actual (reported)January 26, 2015
Actual (reported)June 2016
Date type not reportedThis date has not been verified as actual or estimated.
April 2022
Actual (reported)April 2022
Actual (reported)Anatomical success
Occlusion rate, evaluated using ultrasound scan
4 weeks + 1 year
Clinical success
CEAP, VCSS
4 weeks + 1 year
Peroperative pain
VAS-score
Peroperative
Postoperative pain during 2 weeks post-treatment
VAS-score, used pain medication
During 2 weeks post-treatment
Postoperative complications
4 weeks + 1 year
Disease specific and general health status
4 weeks + 1 year
Time to return to normal daily activities and work
Post-treatment
Duration of the intervention using MOCA
Peroperative
30 patients with primary insufficiency of the GSV with diameters \>/= 12 mm, treated with mechano-chemical ablation (MOCA)
30 patients with insufficient antero-lateral branches, treated with mechano-chemical ablation (MOCA)
30 patients with below-knee GSV insufficiency, treated with mechano-chemical ablation (MOCA)
Treatment with mechano-chemical ablation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with primary insufficiency of the GSV with diameters \>/=12 m m, insufficient antero-lateral branches or below-knee GSV insufficiency
Rijnstate Hospital
Arnhem, Gelderland, 6815 AD, Netherlands
Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg. 2007 Aug;46(2):308-15. doi: 10.1016/j.jvs.2007.03.053. Epub 2007 Jun 27.
Helmy ElKaffas K, ElKashef O, ElBaz W. Great saphenous vein radiofrequency ablation versus standard stripping in the management of primary varicose veins-a randomized clinical trial. Angiology. 2011 Jan;62(1):49-54. doi: 10.1177/0003319710380680. Epub 2010 Aug 18.
Michel Reijnen, MD, PhD
Rijnstate Hospital
45 participants (actual enrollment reported by the registry).
First Submitted
January 19, 2015
First Posted
January 26, 2015
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
3-4 Year Outcomes Following Endovenous Steam Ablation for Venous Insufficiency
Contact the study team to confirm eligibility.
Subramonia S, Lees T. Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins. Br J Surg. 2010 Mar;97(3):328-36. doi: 10.1002/bjs.6867.
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.
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.
Bishawi M, Bernstein R, Boter M, Draughn D, Gould CF, Hamilton C, Koziarski J. Mechanochemical ablation in patients with chronic venous disease: a prospective multicenter report. Phlebology. 2014 Jul;29(6):397-400. doi: 10.1177/0268355513495830. Epub 2013 Jul 2.
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.
Timperman PE. Endovenous laser treatment of incompetent below-knee great saphenous veins. J Vasc Interv Radiol. 2007 Dec;18(12):1495-9. doi: 10.1016/j.jvir.2007.07.029.
Theivacumar NS, Dellagrammaticas D, Mavor AI, Gough MJ. Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial. J Vasc Surg. 2008 Jul;48(1):173-8. doi: 10.1016/j.jvs.2008.01.062. Epub 2008 Apr 28.
Primary Completion
April 2022
Actual (reported)Study Completion
April 2022
Actual (reported)Last Updated
April 27, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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