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

Completed

• Conditions: Dilated Veins; Varicose Veins
• Interventions: Procedure: Mechano-chemical ablation

• Registration Number: NCT02345018
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Study Start: 2016-06
• Status Verified: 2022-04
• Primary Completion: 2022-04
• Study Completion: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GSV below-knee	Mechano-chemical ablation	30 patients with below-knee GSV insufficiency, treated with mechano-chemical ablation (MOCA)
GSV with diameters >/= 12 mm	Mechano-chemical ablation	30 patients with primary insufficiency of the GSV with diameters \>/= 12 mm, treated with mechano-chemical ablation (MOCA)
Antero-lateral branches	Mechano-chemical ablation	30 patients with insufficient antero-lateral branches, treated with mechano-chemical ablation (MOCA)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands