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van CCT (UK)

van CCT (UK)

Beoordeling van mechanochemische endoveneuze behandeling in vergelijking met radiofrequente behandeling van spataderlijden ten gevolge van insufficientie van de vena saphena parva.
Onderzoek in meerdere ziekenhuizen en in opzet van gerandomiseerde studie.

- candidate number17976
- NTR NumberNTR4613
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mei-2014
- Secondary IDsNL42781.100.13 
- Public TitleBeoordeling van mechanochemische endoveneuze behandeling in vergelijking met radiofrequente behandeling van spataderlijden ten gevolge van insufficientie van de vena saphena parva.
Onderzoek in meerdere ziekenhuizen en in opzet van gerandomiseerde studie.
- Scientific TitleMechanochemical Endovenous ablation (MOCATM) versus radiofrequency ablation (RFA) in the treatment of primary Small Saphenous vein Insufficiency: a multicentre randomized trial.

Mechanochemische endoveneuze ablatie versus radiofrequente ablatie in de behandeling van primaire insufficientie van de vena saphena parva: een multi-centrum gerandomiseerde studie
- hypothesisTreatment of small saphenous vein incompetence with MOCATM is associated with anatomical success not inferior to radiofrequency ablation.
- Healt Condition(s) or Problem(s) studiedSmall saphenous vein, Varicose veins
- Inclusion criteria1. Primary SSV incompetence 2. Symptomatic varicose veins, C1-C5 3. Duplex ultrasound criteria meet criteria for general endovenous treatment: diameter of small saphenous vein > 3 mm and < 12 mm, non-tortuous 4. Signed informed consent 5. Patient is willing to participate in follow up 6. Age> 18 year and < 80 year

1. Primaire insufficientie van de VSP 2. symptomatische varices, C1-C5 3. diameter VSP 3-12 mm en niet gekronkeld verloop 4. getekende informer consent 5. bereidheid tot deelnemen follow up. 6. leeftijd 18 tot 80 jaar
- Exclusion criteria1. Patient is incapable of informed consent 2. Pregnancy and lactation 3. C6 varicose veins 4. Pervious surgical or endovenous treatment of the affected vein 5. History of deep venous thrombosis in the affected leg 6. Oral anticoagulants 7. Contraindication or known allergy to sclerosans 8. Immobilization 9. Coagulation disorders or increased risk of thrombo-embolic complications: known coagulation disorders as hemophilia A, hemophilia B, Von Willebrandt disease, Glanzmann disease, factor VII-deficiency, idiopathic trombocytopenic purpura, factor V Leiden, deep venous thrombosis or pulmonary embolism in medical history 10. Fontaine III of IV peripheral arterial disease 11. Severe renal insufficiency: known glomerular filtration rate < 30 mL/min 12. Liver disease, associated with changes in coagulation, anemnestic evidence of bleeding as epistaxis and spontaneous hematoma, liver cirrhosis.

1. PatiŽnt niet in staat tot geven informed consent 2. Zwangerschap of borstvoeding 3. C6 varices 4. Eerdere behandeling aangedane vene dmv chirurgie of endoveneuze therapie. 5. Diep veneuze thrombose in het aangedane been 6. Orale anticoagulantia 7. Contraindicatie of bekende allergie for polidocanol 8. Immobilisatie 9. Stollingstoornissen of verhoogd risico op trombo-embolische complicaties: hemofilie A of B, Ziekte van Von Willebrandt, ziekte van Glanzmann, factor VII- deficiŽntie, idiopathische trombocytopenische purpura, factor V Leiden, DVT or long-embolieŽn in voorgeschiedenis. 10. Perifeer arterieel vaatlijden (fontaine III - IV) 11. Ernstige nierinsufficientie (eGFR <30ml/min) 13. Leverziekten, welke leiden tot stollinsveranderingen en levercirrhose
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-apr-2020
- Target number of participants160
- InterventionsEndovenous ablation of insufficient small saphenous veins by mechanochemical ablation using ClariVein versus radiofrequency ablation by ClosureFast.
- Primary outcomeAnatomical success (at one year follow up) proven by duplex ultrasound.
- Secondary outcomeInitial technical success
Pain during and post treatment
- Timepointsbefore treatment baseline
4 weeks follow up
1 year follow up
2 years follow up
5 years follow up
- Trial web siten/a
- statusstopped
- Sponsor/Initiator Sint Antonius Ziekenhuis, Rijnstate Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Stichting Varysta
- Publications1. Elias S, Raines JK.Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012;27:67-72.
2. Van Eekeren RRJP, Boersma D, Elias S, Holewijn S, Werson DAB, De Vries JPPM, Reijnen MMJP. Mechanochemical endovenous ablation of great saphenous vein incompetence using the ClariVeinģ device: a safety study. J Endovasc Ther. 2011;18:328-334
3. Boersma D, Van Eekeren RRJP, Werson DAB, De Vries JPPM, Reijnen MMJP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVeinģ device: One-year results of a prospective series. EJVES 2013;45(3): 299-303
4. Bishawi M, Bernstein R, Boter M, Draugh D, Gould C, Hamilton C, Koziarski J. Mechanochemical ablation in patients with chronic venous disease: a prospective multicenter report. Phlebology. 2013; Epub ahead of print
- Brief summarySUMMARY
Rationale: In the last decade the treatment of varicose veins endovenous thermal ablation became the gold standard. Although the anatomical success is excellent, major downsides to thermal ablation are pain and nervous injury. Especially in SSV the risk of nervous injury is significant.The novel MOCA treatment is developed to minimize pain and additional injury in ablation. This technique is based on combining mechanical injury to the intima with sclerotherapy. The MESSI study is designed to evaluate MOCA in SSV.
Objective: To evaluate the anatomical success of MOCA versus RFA in treatment of symptomatic insufficient SSV.
Study design: multicentre randomised controlled intervention study.
Study population: 160 patients with symptomatic insufficiency of SSV, 18-80 years, signed informed consent.
Intervention: Group 1: mechanochemical endovenous ablation (ClariVein - catheter). Group 2: endovenous radiofrequency ablation (VNUS ClosureFast catheter).
Main study parameters/endpoints: Primary study parameter is anatomical success rate at one year follow up. Secondary parameters: pain, initial technical success, clinical success, complications and length of procedure.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both intervention modalities are accepted, frequently used and safe. The burden of participation consists of 3 additional out-patient consultations, including duplex, and the use of questionnaires.
- Main changes (audit trail)
- RECORD28-mei-2014 - 25-mei-2017

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