Primary Insufficiency of the GSV With a Diameter >/= 12 mm, Antero-lateral Branches, or Below the Knee (MOCA-XL)

April 26, 2022 updated by: Michel Reijnen, Rijnstate Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary insufficiency of the GSV with diameters >/=12 m m, insufficient antero-lateral branches or below-knee GSV insufficiency

Description

Inclusion Criteria:

  1. Symptomatic varicose veins, C2-C5

  2. Ultrasound criteria:

    1. Diameter supragenual great saphenous vein (GSV) >/= 12 mm , not tortuous; or
    2. Insufficient antero-lateral branch; or
    3. Insufficient below knee GSV
  3. Signed informed consent
  4. Patient consents to follow-up
  5. Age > 18 year en < 80 year

Exclusion Criteria:

  1. Patient is not capable to provide informed consent
  2. Pregnancy and lactation
  3. C6 varicose veins
  4. Previous surgery or endovenous ablation at to treated segment
  5. Deep venous vein thrombosis in medical history
  6. Oral anti-coagulant therapy
  7. Contra-indications or allergy for sclerosant
  8. Immobilisation
  9. 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
  10. Fontaine III of IV peripheral arterial disease
  11. Severe kidney disease: known GFR < 30 ml/min
  12. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GSV with diameters >/= 12 mm
30 patients with primary insufficiency of the GSV with diameters >/= 12 mm, treated with mechano-chemical ablation (MOCA)
Procedure: Mechano-chemical ablation
Treatment with mechano-chemical ablation
Other Names:
  • MOCA
Antero-lateral branches
30 patients with insufficient antero-lateral branches, treated with mechano-chemical ablation (MOCA)
Procedure: Mechano-chemical ablation
Treatment with mechano-chemical ablation
Other Names:
  • MOCA
GSV below-knee
30 patients with below-knee GSV insufficiency, treated with mechano-chemical ablation (MOCA)
Procedure: Mechano-chemical ablation
Treatment with mechano-chemical ablation
Other Names:
  • MOCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomical success
Time Frame: 4 weeks + 1 year
Occlusion rate, evaluated using ultrasound scan
4 weeks + 1 year
Clinical success
Time Frame: 4 weeks + 1 year
CEAP, VCSS
4 weeks + 1 year
Peroperative pain
Time Frame: Peroperative
VAS-score
Peroperative
Postoperative pain during 2 weeks post-treatment
Time Frame: During 2 weeks post-treatment
VAS-score, used pain medication
During 2 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 4 weeks + 1 year
Postoperative complications
4 weeks + 1 year
Disease specific and general health status
Time Frame: 4 weeks + 1 year
AVVQ, SF-36
4 weeks + 1 year
Time to return to normal daily activities and work
Time Frame: Post-treatment
Time to return to normal daily activities and work
Post-treatment
Duration of the intervention using MOCA
Time Frame: Peroperative
Duration of the intervention using MOCA
Peroperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1079-101114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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