Greater Saphenous Vein InjuryMARADONANCT01936168
MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins
A study testing Mechanochemical Endovenous Ablation (MOCA) and Radiofrequency ablation (RFA) in people with Greater Saphenous Vein Injury, run by Rijnstate Hospital at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Greater Saphenous Vein Injury
- What is being tested?
- Mechanochemical Endovenous Ablation (MOCA) and Radiofrequency ablation (RFA)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 5 sitesNetherlands
- Study dates
- 1 Dec 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
BovenIJ Hospital
Amsterdam
OLVG
Amsterdam
Rijnstate Hospital
Arnhem, Gelderland
UMCG
Groningen
St. Antonius Hospital
Nieuwegein
About this study
Official title: Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial
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
- Being tested
- Mechanochemical Endovenous Ablation (MOCA), Radiofrequency ablation (RFA)
- Keywords
- GSV, Primary Varicose Veins, Great Saphenous Vein, Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanochemical Endovenous Ablation (MOCA)Device
Also called (MOCA)
Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence
Radiofrequency ablation (RFA)Procedure or surgery
Also called (RFA)
Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence
| Study group | Role | What they receive |
|---|---|---|
| RFA | Active comparator | Radiofrequency Ablation (RFA) Receives: Procedure: Radiofrequency ablation (RFA) |
| MOCA | Experimental | Mechanochemical Endovenous Ablation (MOCA) Receives: Device: Mechanochemical Endovenous Ablation (MOCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion rate
Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success)
Measured: up to 5 years
Secondary outcomes (7)
Per-procedural pain score
Pain during the procedure will be compared between treatments using the VAS score
Measured: two weeks
Complications
Complication at day 30 will be compared between treatments.
Measured: 30 days
Procedure duration
The duration of the procedures will be compared
Measured: 30 days
Costs of both treatments
The total costs of both treatments will be compared
Measured: 1 year
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.
Measured: 1 year, 5 years
Post procedural pain score
Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score
Measured: two weeks
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.
Measured: 1 year, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study start1 Dec 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Greater Saphenous Vein InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital, OLVG, BovenIJ Hospital
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- MMPJ Reijnen, MD, Principal investigator, Rijnstate Hospital Arnhem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936168
- Sponsor's protocol ID
- 839-130312
- Acronym
- MARADONA
- Status last verified
- Feb 2021
- First submitted
- 2 Sep 2013
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 23312507van 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.
PubMed 21679070van 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.
PubMed 23141679van 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.
PubMed 21854655Holewijn 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.
PubMed 31000063van 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.
PubMed 24726004
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial
- ClinicalTrials.gov ID
- NCT01936168
- Acronym / sponsor ID
- MARADONA / 839-130312
- Conditions
- Greater Saphenous Vein Injury
- Keywords
- GSV, Primary Varicose Veins, Great Saphenous Vein, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- St. Antonius Hospital, OLVG, BovenIJ Hospital
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA | Active comparator | Procedure: Radiofrequency ablation (RFA)Radiofrequency Ablation (RFA) |
| MOCA | Experimental | Device: Mechanochemical Endovenous Ablation (MOCA)Mechanochemical Endovenous Ablation (MOCA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanochemical Endovenous Ablation (MOCA)Also: (MOCA)Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence | Device | MOCA |
| Radiofrequency ablation (RFA)Also: (RFA)Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence | Procedure or surgery | RFA |
Primary outcome
Occlusion rate
Time frame: up to 5 years
Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success)
7 secondary outcomes
Per-procedural pain score
Time frame: two weeks
Complications
Time frame: 30 days
Procedure duration
Time frame: 30 days
Costs of both treatments
Time frame: 1 year
Health status
Time frame: 1 year, 5 years
Post procedural pain score
Time frame: two weeks
Disease related quality of life
Time frame: 1 year, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 23312507Boersma 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.
- Background: PubMed 21679070van 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.
- Background: PubMed 23141679van 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.
- Background: PubMed 21854655van 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.
- Derived from this study: PubMed 31000063Holewijn 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.
- Derived from this study: PubMed 24726004van 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MMPJ Reijnen, MD principal investigator
Rijnstate Hospital Arnhem
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanochemical Endovenous Ablation (MOCA) and Radiofrequency ablation (RFA) in people with Greater Saphenous Vein Injury, run by Rijnstate Hospital at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion rate (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01936168, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.