Safety Distance for Endovenous Laser Ablation of the Great Saphenous Vein

Summary

Chronic venous disease is one of the most common diseases in the western world and worldwide with a prevalence of 83,6%. It is a chronic progressive disease, which causes a significant burden on health systems, treatment and care of these patients. Recurrence of varicose veins after successful treatment remains a problem and has been reported in up to 30% of patients after endovenous laser ablation (EVLA), which is the recommended treatment of choice for incompetence of the truncal veins. The aim of this project is to investigate a variation of the EVLA, which has the potential to reduce the recurrence rate in the long-term. If this assumption is true, the investigators expect reduction of costs in the health system and improved quality of life for individual patients.The primary objective of the project is the evaluation of long-term anatomical effectiveness of EVLA treatment with and without keeping a distance to sapheno-femoral junction (SFJ), defined as complete obliteration of the great saphenous vein (GSV) or absence of an open saphenous stump at the SFJ after 3 years. Secondary objectives are:

1. . Evaluation of the effectiveness of EVLA treatment with and without keeping a distance to SFJ, measured as duplex sonographic reflux (≥ 0,5 sec) in the GSV or any other axial vein at the SFJ after 1 year and 3 years.
2. . Evaluation of the anatomical effectiveness of EVLA treatment with and without keeping a distance to SFJ, measured as the length of the open saphenous stump (in centimeters) after 1 year and 3 years.
3. . Assessment of quality of life 3 months, 1 year and 3 years after EVLA.
4. . Evaluation of the clinical efficacy and tolerability measured as a clinical score at 3 months, 1 year and 3 years after EVLA.
5. . Safety assessment measured as the number of thromboembolic events 1 week and 3 months after EVLA.This project is planned as a prospective randomized parallel group double-blind study.

For the assessment of efficacy and safety parameters, clinical examinations and duplex sonographic examinations will be performed 3 months, 1 year and 3 years after the intervention.

For the assessment of tolerability endpoints, clinical scores and quality of life score will be performed 3 months, 1 year and 3 years after EVLA. Clinical scores include Clinical, Etiologic, Anatomical, and Pathophysiological Classification (CEAP) and Venous Clinical Severity Scoring (VCSS) and for evaluation of quality of life Aberdeen Varicose Veins Questionnaire (AVVQ) will be used.

Conditions

• Great Saphenous Vein Incompetence
• Endovenous Laser Ablation

Interventions

DEVICE

EVLA with keeping of securuty distance

The EVLA will be performed with the 1470nm diode laser and a radial fibre (Leonardo® - 1470 nm/15W, Biolitec). The exact position of the catheter tip will be fixed under ultrasound guidance 2 cm below the SFJ.

DEVICE

EVLA without keeping a distance

The EVLA will be performed with the 1470nm diode laser and a radial fibre (Leonardo® - 1470 nm/15W, Biolitec). The exact position of the catheter tip will be fixed under ultrasound guidance without keeping a distance to the SFJ.

Sponsors & Collaborators

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Stanislava Tzaneva, MD · University Clinic of Dermatology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-26

Primary Completion

2022-08-31

Completion

2023-08-31

Countries

• Austria

Study Locations