Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins (LAST)

Erasmus University

Status: Completed

Conditions: Varicose Veins of Leg With Long Saphenous Vein Distribution; Varicose Veins

Treatments: Procedure: Endovenous laser ablation with 940 nm bare fiber; Procedure: Endovenous steam ablation with steam vein sclerosis system.

Study type: Interventional

Funder types: Other

Identifiers

NCT02046967

ErasmusMC

Details and patient eligibility

About

Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).

Full description

The study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins. The aim of the study is to test whether the anatomical success rate of Steam Ablation is not inferior to that of Endovenous laser ablation (EVLA) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between EVLA and Steam Ablation.

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years old
• Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 s, and diameter of vein > 0.5 cm
• Symptoms of chronic venous insufficiency
• No prior treatment of the insufficient GSV
• Informed consent

Exclusion criteria

• Acute deep or superficial vein thrombosis
• Agenesis of deep vein system
• Vascular malformation or syndrome
• Post-thrombotic syndrome, occlusive type
• Pregnancy
• Immobility
• Allergy to lidocaine
• Arterial insufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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237 participants in 2 patient groups

Endovenous laser ablation

Active Comparator group

Description:

Endovenous laser ablation with 940 nm bare fiber.

Treatment:

Procedure: Endovenous laser ablation with 940 nm bare fiber

Endovenous steam ablation

Active Comparator group

Description:

Endovenous steam ablation with steam vein sclerosis system.

Treatment:

Procedure: Endovenous steam ablation with steam vein sclerosis system.