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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01936168
First Posted: September 5, 2013
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Antonius Hospital
Information provided by (Responsible Party):
Michel Reijnen, Rijnstate Hospital
  Purpose
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.

Condition Intervention
Greater Saphenous Vein Injury Device: Mechanochemical Endovenous Ablation (MOCA) Procedure: Radiofrequency ablation (RFA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial

Resource links provided by NLM:


Further study details as provided by Michel Reijnen, Rijnstate Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Per-procedural pain score [ Time Frame: two weeks ]
    Pain during the procedure will be compared between treatments using the VAS score

  • Complications [ Time Frame: 30 days ]
    Complication at day 30 will be compared between treatments.

  • Procedure duration [ Time Frame: 30 days ]
    The duration of the procedures will be compared

  • Costs of both treatments [ Time Frame: 1 year ]
    The total costs of both treatments will be compared

  • 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.

  • 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

  • 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 Outcome Measures:
  • Recovery time [ Time Frame: 30 days ]
    Time until daily activities and or work can be resumed (measured in days)


Estimated Enrollment: 460
Study Start Date: October 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RFA
Radiofrequency Ablation (RFA)
Procedure: Radiofrequency ablation (RFA)
Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence
Other Name: (RFA)
Experimental: MOCA
Mechanochemical Endovenous Ablation (MOCA)
Device: Mechanochemical Endovenous Ablation (MOCA)
Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence
Other Name: (MOCA)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936168


Locations
Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
BovenIJ Hospital
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
UMCG
Groningen, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
St. Antonius Hospital
Investigators
Principal Investigator: MMPJ Reijnen, MD Rijnstate Hospital Arnhem
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel Reijnen, Surgeon, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT01936168     History of Changes
Other Study ID Numbers: 839-130312
First Submitted: September 2, 2013
First Posted: September 5, 2013
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Michel Reijnen, Rijnstate Hospital:
GSV
Primary Varicose Veins
Great Saphenous Vein
Treatment

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases