NCT03946644: SDEVLA

Safety Distance for Endovenous Laser Ablation of the Great Saphenous Vein

Status unknown NA Last updated 10 May 2019

What this trial tests

NA trial testing EVLA with keeping of securuty distance in Great Saphenous Vein Incompetence in 184 participants. Status unknown.

Timeline

26 September 2018

Primary endpoint
31 August 2022

31 August 2023

Quick facts

Lead sponsor	Medical University of Vienna
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	184
Start date	26 September 2018
Primary completion	31 August 2022
Estimated completion	31 August 2023
Sites	1 location across Austria

Drugs / interventions tested

• EVLA with keeping of securuty distance
• EVLA without keeping a distance

Conditions studied

• Great Saphenous Vein Incompetence — all drugs for Great Saphenous Vein Incompetence →
• Endovenous Laser Ablation — all drugs for Endovenous Laser Ablation →

Sponsor

Medical University of Vienna

Who can join

18 and older, any sex, with Great Saphenous Vein Incompetence or Endovenous Laser Ablation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.