Varicose VeinsMOCA-XLNCT02345018
Primary Insufficiency of the GSV With a Diameter >/= 12 mm, Antero-lateral Branches, or Below the Knee
An observational study of Varicose Veins and Dilated Veins, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The goal of this registry study is to provide insight in the safety and efficacy of treatment with MOCA for primary insufficiency of the GSV with a diameter >/=12mm, insufficient antero-lateral branches and insufficiency of the GSV below the knee. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Varicose Veins, Dilated Veins
- What is being tested?
- Mechano-chemical ablation
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2016to Apr 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary insufficiency of the GSV with diameters >/=12 m m, insufficient antero-lateral branches or below-knee GSV insufficiency
Who may be able to join
- Symptomatic varicose veins, C2-C5
- Ultrasound criteria:
- Diameter supragenual great saphenous vein (GSV) >/= 12 mm , not tortuous; or
- Insufficient antero-lateral branch; or
- Insufficient below knee GSV
- Signed informed consent
- Patient consents to follow-up
- Age > 18 year en < 80 year
Who cannot join
- Patient is not capable to provide informed consent
- Pregnancy and lactation
- C6 varicose veins
- Previous surgery or endovenous ablation at to treated segment
- Deep venous vein thrombosis in medical history
- Oral anti-coagulant therapy
Show all 12Show fewer
- Contra-indications or allergy for sclerosant
- Immobilisation
- Coagulant disorders or increased risk for thrombo-embolic complications: known coagulant disorders such as hemophilia A, hemophilia B, Von Willebrand disease, Glanzmann disease, factor VII-deficiency, idiopathic thrombo-cytopenic purpura, factor V Leiden disease and deep venous thrombosis or lung emboli in medical history
- Fontaine III of IV peripheral arterial disease
- Severe kidney disease: known GFR < 30 ml/min
- Liver diseases accompanied by changes in coagulation of the blood, anamnestic indications for tendency towards haemorrhage , such as epistaxis and spontaneous hematoma, known liver cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registry of the Treatment of Primary Insufficiency of the Great Saphenous Vein With a Diameter >/= 12 mm, Antero-lateral Branches, or Great Saphenous Vein Insufficiency Below the Knee With Mechano-chemical Endovenous Ablation (MOCA)
The goal of this registry study is to provide insight in the safety and efficacy of treatment with MOCA for primary insufficiency of the GSV with a diameter >/=12mm, insufficient antero-lateral branches and insufficiency of the GSV below the knee.
Read the detailed description
Varicose veins are a common problem in the World. From epidemiological studies we know that a quarter of the adult population suffers from some sort of varicose veins. Women suffer two to three times more often from varicose veins than men. The occurrence of varicose veins increase with increasing age and is one of the top ten complaints for which patients visit their general practitioner. De main risk factors for developing varicose veins are enduring standing or sitting, pregnancy, female gender and age. Symptoms are divers and vary from cosmetic complaints to difficult to treat venous ulcers.
Last few years endovenous techniques have been developed for the primary treatment of insufficient varicose veins. Radiofrequent ablation (RFA)is, besides endovenous laser ablation (EVLA), an accepted technique and is frequently applied in clinical practice. This technique, that uses heat, has the important advantage that the treatment can be performed using a slight local anaesthesia. Besides that, RFA causes less hematoma, pain, a superior cosmetic and patient are able to restart daily activities sooner than compared to the classical surgical treatment. Because RFA using heat technology, damage can occur in the surrounding tissues. That is the reason for using tumescent anaesthesia, for which multiple injections are needed. A column of liquid is placed surrounding the vein. Many patients experience this column as inconvenient and despite this form of anaesthesia part of the treated patient population experiences pain after the treatment that can last up to weeks.
A newer endovenous technique is mechano-chemical ablation (MOCA) has been developed, using the ClariVein system. This technique uses intentional mechanical damage to the endothelium of the vene by means of a rotating catheter. At the same time a sclerosans is injected, and as a result the vene occludes. So this technique does not use heat technology. Tumescent anaesthesia is therefore not needed and complications related to techniques using heat (RFA and EVLA) such as burning, pain, hematoma, indurations, and paresthesia could be reduced or even be prevented.
MOCA proved to be a safe and effective alternative treatment for both insufficient great saphenous veins (GSV) and small saphenous veins (SSV). Especially for the treatment of the below-knee GSV and the treatment of superficial branches (such as the antero-lateral branches), there is a risk for damaging nerves that are in the close proximity of these veins.
In a series of 50 patients treated with EVLA for insufficient GSV above the knee, a technical success of 100% was reported after a median follow-up of 7 months, but this was accompanied by nerve damage in 8%. A recent study evaluating MOCA for the treatment of SSV reported an anatomical success of 96% without any nerve damage or other major complications. Therefore, MOCA could be an alternative for the treatment of various insufficient varicose vein segments without causing nerve damage.
The choice of treatment for patients with both above and below knee GSV insufficiency is nowadays only endovenous ablation of the above-knee segment. However, Theivacumar and co-workers recently showed that in these patients there is a significant residual reflux in approximately 41% of treated legs. These patients clearly showed less clinical improvement and approximately 90% of these patients needed additional treatment.
Up to now it is unknown whether treatment with MOCA can yield comparable results when used to treat insufficient GSV with diameters >= 12 mm, insufficient antero-lateral branches and insufficient GSV below the knee. The goal of this registry study is to provide insight in the safety and efficacy of treatment of the above described insufficient varicose vein segments.
- Conditions
- Varicose Veins, Dilated Veins
- Being tested
- Mechano-chemical ablation
- Keywords
- Mechano-chemical ablation, Treatment large varicose veins, Below-knee and branches, Endovenous
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechano-chemical ablationProcedure or surgery
Also called MOCA
Treatment with mechano-chemical ablation
| Study group | Role | What they receive |
|---|---|---|
| GSV with diameters >/= 12 mm | 30 patients with primary insufficiency of the GSV with diameters >/= 12 mm, treated with mechano-chemical ablation (MOCA) Receives: Procedure: Mechano-chemical ablation | |
| Antero-lateral branches | 30 patients with insufficient antero-lateral branches, treated with mechano-chemical ablation (MOCA) Receives: Procedure: Mechano-chemical ablation | |
| GSV below-knee | 30 patients with below-knee GSV insufficiency, treated with mechano-chemical ablation (MOCA) Receives: Procedure: Mechano-chemical ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical success
Occlusion rate, evaluated using ultrasound scan
Measured: 4 weeks + 1 year
Clinical success
CEAP, VCSS
Measured: 4 weeks + 1 year
Peroperative pain
VAS-score
Measured: Peroperative
Postoperative pain during 2 weeks post-treatment
VAS-score, used pain medication
Measured: During 2 weeks post-treatment
Secondary outcomes (4)
Postoperative complications
Postoperative complications
Measured: 4 weeks + 1 year
Disease specific and general health status
AVVQ, SF-36
Measured: 4 weeks + 1 year
Time to return to normal daily activities and work
Time to return to normal daily activities and work
Measured: Post-treatment
Duration of the intervention using MOCA
Duration of the intervention using MOCA
Measured: Peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJun 2016
- Primary completionApr 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- Michel Reijnen, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345018
- Sponsor's protocol ID
- 1079-101114
- Acronym
- MOCA-XL
- Status last verified
- Apr 2022
- First submitted
- 19 Jan 2015
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg. 2007 Aug;46(2):308-15. doi: 10.1016/j.jvs.2007.03.053. Epub 2007 Jun 27.
PubMed 17600655Helmy ElKaffas K, ElKashef O, ElBaz W. Great saphenous vein radiofrequency ablation versus standard stripping in the management of primary varicose veins-a randomized clinical trial. Angiology. 2011 Jan;62(1):49-54. doi: 10.1177/0003319710380680. Epub 2010 Aug 18.
PubMed 20724299Subramonia S, Lees T. Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins. Br J Surg. 2010 Mar;97(3):328-36. doi: 10.1002/bjs.6867.
PubMed 20035541van 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 21679070Boersma 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 23312507Bishawi M, Bernstein R, Boter M, Draughn D, Gould CF, Hamilton C, Koziarski J. Mechanochemical ablation in patients with chronic venous disease: a prospective multicenter report. Phlebology. 2014 Jul;29(6):397-400. doi: 10.1177/0268355513495830. Epub 2013 Jul 2.
PubMed 23820117van 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 23141679Timperman PE. Endovenous laser treatment of incompetent below-knee great saphenous veins. J Vasc Interv Radiol. 2007 Dec;18(12):1495-9. doi: 10.1016/j.jvir.2007.07.029.
PubMed 18057283Theivacumar NS, Dellagrammaticas D, Mavor AI, Gough MJ. Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial. J Vasc Surg. 2008 Jul;48(1):173-8. doi: 10.1016/j.jvs.2008.01.062. Epub 2008 Apr 28.
PubMed 18440756
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of the Treatment of Primary Insufficiency of the Great Saphenous Vein With a Diameter >/= 12 mm, Antero-lateral Branches, or Great Saphenous Vein Insufficiency Below the Knee With Mechano-chemical Endovenous Ablation (MOCA)
- ClinicalTrials.gov ID
- NCT02345018
- Acronym / sponsor ID
- MOCA-XL / 1079-101114
- Conditions
- Varicose Veins, Dilated Veins
- Keywords
- Mechano-chemical ablation, Treatment large varicose veins, Below-knee and branches, Endovenous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Apr 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 26 Jan 2015 (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 goal of this registry study is to provide insight in the safety and efficacy of treatment with MOCA for primary insufficiency of the GSV with a diameter >/=12mm, insufficient antero-lateral branches and insufficiency of the GSV below the knee.
Detailed description
Varicose veins are a common problem in the World. From epidemiological studies we know that a quarter of the adult population suffers from some sort of varicose veins. Women suffer two to three times more often from varicose veins than men. The occurrence of varicose veins increase with increasing age and is one of the top ten complaints for which patients visit their general practitioner. De main risk factors for developing varicose veins are enduring standing or sitting, pregnancy, female gender and age. Symptoms are divers and vary from cosmetic complaints to difficult to treat venous ulcers.
Last few years endovenous techniques have been developed for the primary treatment of insufficient varicose veins. Radiofrequent ablation (RFA)is, besides endovenous laser ablation (EVLA), an accepted technique and is frequently applied in clinical practice. This technique, that uses heat, has the important advantage that the treatment can be performed using a slight local anaesthesia. Besides that, RFA causes less hematoma, pain, a superior cosmetic and patient are able to restart daily activities sooner than compared to the classical surgical treatment. Because RFA using heat technology, damage can occur in the surrounding tissues. That is the reason for using tumescent anaesthesia, for which multiple injections are needed. A column of liquid is placed surrounding the vein. Many patients experience this column as inconvenient and despite this form of anaesthesia part of the treated patient population experiences pain after the treatment that can last up to weeks.
A newer endovenous technique is mechano-chemical ablation (MOCA) has been developed, using the ClariVein system. This technique uses intentional mechanical damage to the endothelium of the vene by means of a rotating catheter. At the same time a sclerosans is injected, and as a result the vene occludes. So this technique does not use heat technology. Tumescent anaesthesia is therefore not needed and complications related to techniques using heat (RFA and EVLA) such as burning, pain, hematoma, indurations, and paresthesia could be reduced or even be prevented.
MOCA proved to be a safe and effective alternative treatment for both insufficient great saphenous veins (GSV) and small saphenous veins (SSV). Especially for the treatment of the below-knee GSV and the treatment of superficial branches (such as the antero-lateral branches), there is a risk for damaging nerves that are in the close proximity of these veins.
In a series of 50 patients treated with EVLA for insufficient GSV above the knee, a technical success of 100% was reported after a median follow-up of 7 months, but this was accompanied by nerve damage in 8%. A recent study evaluating MOCA for the treatment of SSV reported an anatomical success of 96% without any nerve damage or other major complications. Therefore, MOCA could be an alternative for the treatment of various insufficient varicose vein segments without causing nerve damage.
The choice of treatment for patients with both above and below knee GSV insufficiency is nowadays only endovenous ablation of the above-knee segment. However, Theivacumar and co-workers recently showed that in these patients there is a significant residual reflux in approximately 41% of treated legs. These patients clearly showed less clinical improvement and approximately 90% of these patients needed additional treatment.
Up to now it is unknown whether treatment with MOCA can yield comparable results when used to treat insufficient GSV with diameters >= 12 mm, insufficient antero-lateral branches and insufficient GSV below the knee. The goal of this registry study is to provide insight in the safety and efficacy of treatment of the above described insufficient varicose vein segments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSV with diameters >/= 12 mm | – | Procedure: Mechano-chemical ablation30 patients with primary insufficiency of the GSV with diameters >/= 12 mm, treated with mechano-chemical ablation (MOCA) |
| Antero-lateral branches | – | Procedure: Mechano-chemical ablation30 patients with insufficient antero-lateral branches, treated with mechano-chemical ablation (MOCA) |
| GSV below-knee | – | Procedure: Mechano-chemical ablation30 patients with below-knee GSV insufficiency, treated with mechano-chemical ablation (MOCA) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary insufficiency of the GSV with diameters >/=12 m m, insufficient antero-lateral branches or below-knee GSV insufficiency
Key inclusion criteria (8 listed)
- Symptomatic varicose veins, C2-C5
- Ultrasound criteria:
- Signed informed consent
- Patient consents to follow-up
- Age > 18 year en < 80 year
Key exclusion criteria (12 listed)
- Patient is not capable to provide informed consent
- Pregnancy and lactation
- C6 varicose veins
- Previous surgery or endovenous ablation at to treated segment
- Deep venous vein thrombosis in medical history
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 |
|---|---|---|
| Mechano-chemical ablationAlso: MOCATreatment with mechano-chemical ablation | Procedure or surgery | Antero-lateral branches, GSV below-knee, GSV with diameters >/= 12 mm |
Primary outcome
Anatomical success
Time frame: 4 weeks + 1 year
Occlusion rate, evaluated using ultrasound scan
Clinical success
Time frame: 4 weeks + 1 year
CEAP, VCSS
Peroperative pain
Time frame: Peroperative
VAS-score
Postoperative pain during 2 weeks post-treatment
Time frame: During 2 weeks post-treatment
VAS-score, used pain medication
4 secondary outcomes
Postoperative complications
Time frame: 4 weeks + 1 year
Disease specific and general health status
Time frame: 4 weeks + 1 year
Time to return to normal daily activities and work
Time frame: Post-treatment
Duration of the intervention using MOCA
Time frame: Peroperative
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 27 Apr 2022.
- Background: PubMed 17600655Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg. 2007 Aug;46(2):308-15. doi: 10.1016/j.jvs.2007.03.053. Epub 2007 Jun 27.
- Background: PubMed 20724299Helmy ElKaffas K, ElKashef O, ElBaz W. Great saphenous vein radiofrequency ablation versus standard stripping in the management of primary varicose veins-a randomized clinical trial. Angiology. 2011 Jan;62(1):49-54. doi: 10.1177/0003319710380680. Epub 2010 Aug 18.
- Background: PubMed 20035541Subramonia S, Lees T. Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins. Br J Surg. 2010 Mar;97(3):328-36. doi: 10.1002/bjs.6867.
- 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 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 23820117Bishawi M, Bernstein R, Boter M, Draughn D, Gould CF, Hamilton C, Koziarski J. Mechanochemical ablation in patients with chronic venous disease: a prospective multicenter report. Phlebology. 2014 Jul;29(6):397-400. doi: 10.1177/0268355513495830. Epub 2013 Jul 2.
- 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 18057283Timperman PE. Endovenous laser treatment of incompetent below-knee great saphenous veins. J Vasc Interv Radiol. 2007 Dec;18(12):1495-9. doi: 10.1016/j.jvir.2007.07.029.
- Background: PubMed 18440756Theivacumar NS, Dellagrammaticas D, Mavor AI, Gough MJ. Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial. J Vasc Surg. 2008 Jul;48(1):173-8. doi: 10.1016/j.jvs.2008.01.062. Epub 2008 Apr 28.
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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.
Michel Reijnen, MD, PhD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Dilated Veins, run by Rijnstate Hospital at 1 site 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 8 inclusion and 12 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Anatomical success (time frame: 4 weeks + 1 year). The study lists 4 primary outcomes in all. 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 NCT02345018, which also lists 9 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 27 Apr 2022.