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Completed

NCT Number: NCT01936168

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

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.

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Key information

Conditions

Greater Saphenous Vein Injury

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital, Arnhem, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanochemical Endovenous Ablation (MOCA)

Device

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

Other names: (MOCA)

Radiofrequency ablation (RFA)

Procedure

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

Other names: (RFA)

Primary outcomes

  1. Occlusion rate

    Time frame: up to 5 years

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

Secondary outcomes

  1. Per-procedural pain score

    Time frame: two weeks

    Pain during the procedure will be compared between treatments using the VAS score

  2. Complications

    Time frame: 30 days

    Complication at day 30 will be compared between treatments.

  3. Procedure duration

    Time frame: 30 days

    The duration of the procedures will be compared

  4. Costs of both treatments

    Time frame: 1 year

    The total costs of both treatments will be compared

  5. Health status

    Time frame: 1 year, 5 years

    Using the RAND 36-Item short From Health Survey (SF36) the general health status will be compared between treatments at various time points as specified by the protocol.

  6. Post procedural pain score

    Time frame: two weeks

    Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score

  7. Disease related quality of life

    Time frame: 1 year, 5 years

    Using the Aberdeen Varicose Vein Questionnaire (AVVQ)the disease related quality of life will be compared between treatments at various time points as specified by the protocol.

Other outcomes

  1. Recovery time

    Time frame: 30 days

    Time until daily activities and or work can be resumed (measured in days)

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • BovenIJ Hospital
  • OLVG
  • St. Antonius Hospital

Registry information

Official study title

Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial

Acronym: MARADONA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 5, 2013
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.