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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Rijnstate Hospital
Sponsor:
Collaborator:
St. Antonius Hospital
Information provided by (Responsible Party):
Michel Reijnen, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01936168
First received: September 2, 2013
Last updated: September 9, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Rijnstate Hospital:

Primary Outcome Measures:
  • Occlusion rate [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Pain during the procedure will be compared between treatments using the VAS score

  • Complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Complication at day 30 will be compared between treatments.

  • Procedure duration [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The duration of the procedures will be compared

  • Costs of both treatments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The total costs of both treatments will be compared

  • Health status [ Time Frame: 1 year, 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
Device: Mechanochemical Endovenous Ablation (MOCA)
Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence
Other Name: (MOCA)
Experimental: MOCA
Mechanochemical Endovenous Ablation (MOCA)
Procedure: Radiofrequency ablation (RFA)
Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence
Other Name: (RFA)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936168

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands
Contact: Ramon Eekeren, van, MD    088-0058888    rvaneekeren@rijnstate.nl   
Contact: Michel Reijnen, MD, PhD    088-0058888    mreijnen@rijnstate.nl   
Principal Investigator: Michel Reijnen, MD,PhD         
Centrum Oosterwal Not yet recruiting
Alkmaar, Netherlands
Contact: J Lawson         
Contact: S Gauw         
Principal Investigator: J Lawson         
BovenIJ Hospital Not yet recruiting
Amsterdam, Netherlands
Contact: A Vahl         
Contact: M Haenen         
Principal Investigator: A Vahl         
OLVG Not yet recruiting
Amsterdam, Netherlands
Contact: A Vahl         
Contact: M Mok         
Principal Investigator: A Vahl         
St. Antonius Hospital Recruiting
Nieuwegein, Netherlands
Contact: Doeke Boersma    088 320 3000      
Contact: Debbie Werson    088 320 3000    d.werson@antoniusziekenhuis.nl   
Principal Investigator: Jean Paul de Vries, MD, PhD         
Sponsors and Collaborators
Rijnstate Hospital
St. Antonius Hospital
Investigators
Principal Investigator: MMPJ Reijnen, MD Rijnstate Hospital Arnhem
  More Information

Publications:
Additional 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
Study First Received: September 2, 2013
Last Updated: September 9, 2013
Health Authority: Netherlands: Independent Ethics Committee

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

Additional relevant MeSH terms:
Varicose Veins
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014