MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Greater Saphenous Vein Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RFA

Radiofrequency Ablation (RFA)

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation (RFA)

Intervention Type PROCEDURE

Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence

MOCA

Mechanochemical Endovenous Ablation (MOCA)

Group Type EXPERIMENTAL

Mechanochemical Endovenous Ablation (MOCA)

Intervention Type DEVICE

Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence

Interventions

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Mechanochemical Endovenous Ablation (MOCA)

Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence

Intervention Type DEVICE

Radiofrequency ablation (RFA)

Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence

Intervention Type PROCEDURE

Other Intervention Names

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(MOCA) (RFA)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No