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

Primary Purpose

Greater Saphenous Vein Injury

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mechanochemical Endovenous Ablation (MOCA)
Radiofrequency ablation (RFA)
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Greater Saphenous Vein Injury focused on measuring GSV, Primary Varicose Veins, Great Saphenous Vein, Treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate Hospital
  • BovenIJ Hospital
  • OLVG
  • UMCG
  • St. Antonius Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RFA

MOCA

Arm Description

Radiofrequency Ablation (RFA)

Mechanochemical Endovenous Ablation (MOCA)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Per-procedural pain score
Pain during the procedure will be compared between treatments using the VAS score
Complications
Complication at day 30 will be compared between treatments.
Procedure duration
The duration of the procedures will be compared
Costs of both treatments
The total costs of both treatments will be compared
Health status
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
Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score
Disease related quality of life
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.

Full Information

First Posted
September 2, 2013
Last Updated
February 11, 2021
Sponsor
Rijnstate Hospital
Collaborators
St. Antonius Hospital, OLVG, BovenIJ Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01936168
Brief Title
MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins
Acronym
MARADONA
Official Title
Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rijnstate Hospital
Collaborators
St. Antonius Hospital, OLVG, BovenIJ Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Greater Saphenous Vein Injury
Keywords
GSV, Primary Varicose Veins, Great Saphenous Vein, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RFA
Arm Type
Active Comparator
Arm Description
Radiofrequency Ablation (RFA)
Arm Title
MOCA
Arm Type
Experimental
Arm Description
Mechanochemical Endovenous Ablation (MOCA)
Intervention Type
Device
Intervention Name(s)
Mechanochemical Endovenous Ablation (MOCA)
Other Intervention Name(s)
(MOCA)
Intervention Description
Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation (RFA)
Other Intervention Name(s)
(RFA)
Intervention Description
Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence
Primary Outcome Measure Information:
Title
Occlusion rate
Description
Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success)
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Per-procedural pain score
Description
Pain during the procedure will be compared between treatments using the VAS score
Time Frame
two weeks
Title
Complications
Description
Complication at day 30 will be compared between treatments.
Time Frame
30 days
Title
Procedure duration
Description
The duration of the procedures will be compared
Time Frame
30 days
Title
Costs of both treatments
Description
The total costs of both treatments will be compared
Time Frame
1 year
Title
Health status
Description
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.
Time Frame
1 year, 5 years
Title
Post procedural pain score
Description
Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score
Time Frame
two weeks
Title
Disease related quality of life
Description
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.
Time Frame
1 year, 5 years
Other Pre-specified Outcome Measures:
Title
Recovery time
Description
Time until daily activities and or work can be resumed (measured in days)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MMPJ Reijnen, MD
Organizational Affiliation
Rijnstate Hospital Arnhem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
Country
Netherlands
Facility Name
BovenIJ Hospital
City
Amsterdam
Country
Netherlands
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Facility Name
UMCG
City
Groningen
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
23312507
Citation
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.
Results Reference
background
PubMed Identifier
21679070
Citation
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.
Results Reference
background
PubMed Identifier
23141679
Citation
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.
Results Reference
background
PubMed Identifier
21854655
Citation
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.
Results Reference
background
PubMed Identifier
31000063
Citation
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.
Results Reference
derived
PubMed Identifier
24726004
Citation
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.
Results Reference
derived

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

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