MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins

NCT01936168 | Completed

• 1 other identifier: 839-130312
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 5

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.

Conditions

Greater Saphenous Vein Injury

Keywords

GSV; Primary Varicose Veins; Great Saphenous Vein; Treatment

Outcome Measures

Primary Outcomes (1)

• Occlusion rate

  Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success)

  up to 5 years

Secondary Outcomes (7)

• Per-procedural pain score

  two weeks

• Complications

  30 days

• Procedure duration

  30 days

• Costs of both treatments

  1 year

• Health status

  1 year, 5 years

Other Outcomes (1)

• Recovery time

  30 days

Study Arms (2)

RFA

ACTIVE COMPARATOR

Radiofrequency Ablation (RFA)

Procedure: Radiofrequency ablation (RFA)

MOCA

EXPERIMENTAL

Mechanochemical Endovenous Ablation (MOCA)

Device: Mechanochemical Endovenous Ablation (MOCA)

Interventions

Mechanochemical Endovenous Ablation (MOCA) DEVICE

Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence

Also known as: (MOCA)

MOCA

Radiofrequency ablation (RFA) PROCEDURE

Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence

Also known as: (RFA)

RFA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• St. Antonius Hospital: collaborator
• OLVG: collaborator
• BovenIJ Hospital: collaborator

Study Sites (5)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Location

BovenIJ Hospital

Amsterdam, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

UMCG

Groningen, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 23312507 BACKGROUND

• 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.

  PMID: 21679070 BACKGROUND

• 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.

  PMID: 23141679 BACKGROUND

• 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.

  PMID: 21854655 BACKGROUND

• 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.

  PMID: 31000063 DERIVED

• 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.

  PMID: 24726004 DERIVED

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• MMPJ Reijnen, MD

  Rijnstate Hospital Arnhem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 5, 2013
• Study Start: December 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

NL (5)