Safety Distance for Endovenous Laser Ablation of the Great Saphenous Vein

NCT03946644 | Unknown DMC

• 1 other identifier: 62018
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.. Assessment of quality of life 3 months, 1 year and 3 years after EVLA.
4. 4.. Evaluation of the clinical efficacy and tolerability measured as a clinical score at 3 months, 1 year and 3 years after EVLA.
5. 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.

Conditions

Great Saphenous Vein Incompetence; Endovenous Laser Ablation

Keywords

Safety distance; Laser ablation; Great saphenous vein

Outcome Measures

Primary Outcomes (1)

• Number of Complete obliteration of the GSV or absence of an open saphenous stump at the SFJ 3 years after EVLA

  Number of complete obliteration of the GSV or absence of an open saphenous stump will be assessed by duplex-sonographic investigation

  3 years

Secondary Outcomes (5)

• Number of GSV with Duplex sonographic reflux (≥ 0,5 sec) or any other axial vein at the SFJ

  1 year and 3 years

• Length of the open saphenous stump (in centimeters)

  1 year and 3 years

• Satisfaction assessed by the QOL

  3 months, 1 year, 3 years

• points of Clinical score

  3 months, 1 year, 3 years

• Incidence of treatment-emergent adverse events assessed as Number of thromboembolic events

  1 week, 3 months

Study Arms (2)

EVLA with keeping of security distance

ACTIVE COMPARATOR

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 with keeping of securuty distance

EVLA without keeping a distance

EXPERIMENTAL

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.

Device: EVLA without keeping a distance

Interventions

EVLA with keeping of securuty distance DEVICE

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.

EVLA with keeping of security distance

EVLA without keeping a distance DEVICE

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.

EVLA without keeping a distance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Duplex sonographic reflux in GSV ≥ 0,5 seconds
• Straight run of the GSV in the thigh

You may not qualify if:

• Acute thromboembolic events
• Active cancer
• Postthrombotic syndrome from obstruction type
• Severe peripheral arterial occlusive disease (PAOD, ankle brachial index (ABI) ≤ 0.5)
• Pregnancy and breast feeding
• Incompetence of the anterior accessory great saphenous vein (AAGSV)
• Intolerance for compression stockings
• Contraindications for local anesthesia or general anaesthesia

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Study Officials

• Stanislava Tzaneva, MD

  University Clinic of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanislava Tzaneva, MD

CONTACT

+4314040077020; stanislava.tzaneva@meduniwien.ac.at

Kornelia Boehler, MD

CONTACT

+4314040077020; kornelia.boehler@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The blinding of the patients is facilitated by the same mode schedule and the same treatment performance for both allocations. The patients will not be informed of their treatment allocation. The clinical investigator who will prepare the follow-up investigations will not have information about treatment allocation too. The blinded investigator will not have access to the full documentation of the study and to randomizing data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: At day 0 (day of EVLA), 7-14 days after inclusion of the patients, patients will be randomized with the online randomization program "Randomizer" (https://www.meduniwien.ac.at/randomizer/web/login.php).Patients will be randomized to one of the following two groups: * EVLA with keeping of security distance of 2cm to the SFJ * EVLA without keeping a distance tot he SFJ

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: May 10, 2019
• Study Start: September 26, 2018
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2023
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)