ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02345018
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Michel Reijnen, Rijnstate Hospital

Brief 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.

Condition or disease Intervention/treatment
Varicose Veins Dilated Veins Procedure: Mechano-chemical ablation

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 [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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)
Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

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 Name: 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 Name: 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 Name: MOCA




Primary Outcome Measures :
  1. Anatomical success [ Time Frame: 4 weeks + 1 year ]
    Occlusion rate, evaluated using ultrasound scan

  2. Clinical success [ Time Frame: 4 weeks + 1 year ]
    CEAP, VCSS

  3. Peroperative pain [ Time Frame: Peroperative ]
    VAS-score

  4. Postoperative pain during 2 weeks post-treatment [ Time Frame: During 2 weeks post-treatment ]
    VAS-score, used pain medication


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 4 weeks + 1 year ]
    Postoperative complications

  2. Disease specific and general health status [ Time Frame: 4 weeks + 1 year ]
    AVVQ, SF-36

  3. Time to return to normal daily activities and work [ Time Frame: Post-treatment ]
    Time to return to normal daily activities and work

  4. Duration of the intervention using MOCA [ Time Frame: Peroperative ]
    Duration of the intervention using MOCA



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345018


Contacts
Contact: Daphne Veen, van der 003188 005 72 82 dvanderveen@rijnstate.nl
Contact: Suzanne Holewijn, PhD 003188 005 72 82 sholewijn@rijnstate.nl

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands, 6815 AD
Contact: Daphne van der Veen    088 005 72 82    dvanderveen@rijnstate.nl   
Contact: Suzanne Holewijn    088 005 72 82    sholewijn@rijnstate.nl   
Principal Investigator: Michel Reijnen         
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: Michel Reijnen, MD, PhD Rijnstate Hospital

Publications:

Responsible Party: Michel Reijnen, Vascular surgeon, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT02345018     History of Changes
Other Study ID Numbers: 1079-101114
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Michel Reijnen, Rijnstate Hospital:
Mechano-chemical ablation
Treatment large varicose veins
Below-knee and branches
Endovenous

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases