EVLA and Optimal Timing of Sclerotherapy (FinnTrunk)

FinnTrunk, EVLA and Optimal Timing of Sclerotherapy

The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Reflux
• Intervention / Treatment: Procedure: Endovenous laser ablation

Detailed Description

The study inclusion criteria is patients with main trunk (VSM, SSV, AASV) reflux to be treated with EVLA, suffering C2-C3 varicose disease, age 18-years and no severe co-morbidities.

Patients with written consent will be randomized to two primary treatments groups; EVLA only and EVLA combined with sclerotherapy of varicose tributaries. The primary outcome is the requirement additional sclerotherapy on 3 month control visit. Other study outcomes are pain, quality of life (veins questionnaire), severity score and also recurring of varicose disease at 1, 3 and 5 years.

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harri Hakovirta, Professor; Phone Number: +358405918811; Email: haheha@utu.fi
• Study Contact Backup: Name: Khalil Firoozi, MD; Phone Number: +35823130000; Email: khalil.firoozi@tyks.fi

Study Locations

• Finland
  • Turku, Finland, 20520
    • Turku University Hospital
    • Contact: Khalil Firoozi, MD; Phone Number: +35823130000; Email: khalil.firoozi@tyks.fi
    • Contact: Harri Hakovirta, Professor; Phone Number: +35823130000; Email: harri.hakovirta@tyks.fi
    • Sub-Investigator: Jaakko Viljamaa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Varicose disease of lower extremity caused by reflux of VSM, SSV or AASV to be treated with EVLA. Age over 18 years. Clinical symptoms C2-3.

Exclusion Criteria:

• No severe comorbidities. Previous DVT.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EVLA only; Only main trunk/trunks with venous reflux will be treated	Procedure: Endovenous laser ablation; The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment; Other Names: Endovenous laser ablation combined with foam sclerotherapy of varicose tributaries
Active Comparator: EVLA and sclerotherapy of tributaries; Main trunk/trunks with venous reflux will be treated combined with foam sclerotherapy	Procedure: Endovenous laser ablation; The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment; Other Names: Endovenous laser ablation combined with foam sclerotherapy of varicose tributaries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
re-intervention	Requirement of re-intervention	3 months
Pain after procedure	Post procedural pain measured with VAS scale	up to 3 months after the treatment
Quality of life before after procedure	Quality of life will be measured with Veins questionnaire	up to 5 years
Recur	The recurring varicose veins	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications	Infections, DVT, Pulmonary embolus will be reported	3 months

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Helsinki University Central Hospital; Oulu University Hospital; Satasairaala; Tampere University Hospital; Päijänne Tavastia Central Hospital; Vaasa Central Hospital, Vaasa, Finland
• Investigators: Study Chair: Harri Hakovirta, Professor, University of Turku

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2021
• Primary Completion (Anticipated): March 15, 2027
• Study Completion (Anticipated): March 15, 2030

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 93 /1801/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No