Primary Insufficiency of the GSV With a Diameter >/= 12 mm, Antero-lateral Branches, or Below the Knee
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)
1 other identifier
observational
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedApril 27, 2022
April 1, 2022
5.8 years
January 19, 2015
April 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (4)
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
Study Arms (3)
GSV with diameters >/= 12 mm
30 patients with primary insufficiency of the GSV with diameters \>/= 12 mm, treated with mechano-chemical ablation (MOCA)
Antero-lateral branches
30 patients with insufficient antero-lateral branches, treated with mechano-chemical ablation (MOCA)
GSV below-knee
30 patients with below-knee GSV insufficiency, treated with mechano-chemical ablation (MOCA)
Interventions
Treatment with mechano-chemical ablation
Eligibility Criteria
Patients with primary insufficiency of the GSV with diameters \>/=12 m m, insufficient antero-lateral branches or below-knee GSV insufficiency
You may qualify if:
- Symptomatic varicose veins, C2-C5
- Ultrasound criteria:
- Diameter supragenual great saphenous vein (GSV) \>/= 12 mm , not tortuous; or
- Insufficient antero-lateral branch; or
- Insufficient below knee GSV
- Signed informed consent
- Patient consents to follow-up
- Age \> 18 year en \< 80 year
You may not qualify if:
- Patient is not capable to provide informed consent
- Pregnancy and lactation
- C6 varicose veins
- Previous surgery or endovenous ablation at to treated segment
- Deep venous vein thrombosis in medical history
- Oral anti-coagulant therapy
- Contra-indications or allergy for sclerosant
- Immobilisation
- Coagulant disorders or increased risk for thrombo-embolic complications: known coagulant disorders such as hemophilia A, hemophilia 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
- Fontaine III of IV peripheral arterial disease
- Severe kidney disease: known GFR \< 30 ml/min
- Liver diseases accompanied by changes in coagulation of the blood, anamnestic indications for tendency towards haemorrhage , such as epistaxis and spontaneous hematoma, known liver cirrhosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rijnstate Hospital
Arnhem, Gelderland, 6815 AD, Netherlands
Related Publications (9)
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.
PMID: 17600655BACKGROUNDHelmy 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.
PMID: 20724299BACKGROUNDSubramonia 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.
PMID: 20035541BACKGROUNDvan 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.
PMID: 21679070BACKGROUNDBoersma 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.
PMID: 23312507BACKGROUNDBishawi 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.
PMID: 23820117BACKGROUNDvan 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.
PMID: 23141679BACKGROUNDTimperman 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.
PMID: 18057283BACKGROUNDTheivacumar 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.
PMID: 18440756BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Reijnen, MD, PhD
Rijnstate Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vascular surgeon
Study Record Dates
First Submitted
January 19, 2015
First Posted
January 26, 2015
Study Start
June 1, 2016
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
April 27, 2022
Record last verified: 2022-04