PREservation Versus Thermal Ablation

NCT04034329 | Unknown

• 1 other identifier: 20140451
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be looking at the effect of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).

Conditions

Varicose Veins

Keywords

ASVAL; EVLA; GSV; Long-term efficacy

Outcome Measures

Primary Outcomes (10)

• Number of Participants with pain or other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)

  None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily limiting most regular daily activities (3)

  2-5 years

• Number of Participants with varicose Veins from absent (score 0) to severe (score 3).

  None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)

  2-5 years

• Number of Participants with venous oedema from absent (score 0) to severe (score 3).

  None (0) Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)

  2-5 years

• Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).

  None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)

  2-5 years

• Number of Participants with inflammation from absent (score 0) to severe (score 3).

  None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)

  2-5 years

• Number of Participants with induration from absent (score 0) to severe (score 3).

  None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)

  2-5 years

• Number of Participants with active ulcers from absent (score 0) to severe (score 3).

  None (0), 1 (1), 2 (2), more than 2 (3)

  2-5 years

• Number of Participants with different duration of active ulcer: from absent (score 0) to severe (score 3).

  None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)

  2-5 years

• Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).

  None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)

  2-5 years

• Number of Participants with compression therapy from absent (score 0) to severe (score 3).

  Not used (0), Intermittent use of stockings (1), Uses stockings most days (2), Full compliance with stockings (3)

  2-5 years

Secondary Outcomes (1)

• Number of Participants with clinical recurrence-free rate (no - score 0, yes - score 1)

  2-5 years

Study Arms (2)

ASVAL - group

GSV diameter ≤ 6 mm

Procedure: ASVAL

EVLA-group

GSV diameter \> 6 mm

Procedure: EVLA

Interventions

ASVAL PROCEDURE

Ambulatory Selective Varices Ablation under Local Anesthesia

ASVAL - group

EVLA PROCEDURE

Endovenous Laser Ablation

EVLA-group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with GSV incompetence and C2-C3 were included in the prospective consecutive case study if they satisfied the selection criteria

You may qualify if:

• Great saphenous vein (GSV) incompetence with reflux at least down to the knee level
• Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C2-C3
• Physical status according to American Society of Anesthesiologists (ASA) I-II (I-Healthy, non-smoking, no or minimal alcohol use; II-Mild diseases only without substantive functional limitations)

You may not qualify if:

• Previous surgical groin exploration, except herniotomy
• Small saphenous vein, anterior or posterior accessory saphenous vein incompetence at the same limb
• Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome
• Arterial occlusive disease more severe than Intermittent claudication after more than 200 meters of pain free walking (Fontaine IIA) and/or ankle brachial index below 0.8

Sponsors & Collaborators

• Belarusian State Medical University: lead

Study Sites (1)

Educational Institution"Belarusian State Medical University"

Minsk, Dzerzhinski Ave., 83, 220116, Belarus

Location

Related Publications (7)

• Pittaluga P, Chastanet S. Persistent incompetent truncal veins should not be treated immediately. Phlebology. 2015 Mar;30(1 Suppl):98-106. doi: 10.1177/0268355515569141.

  PMID: 25729076 BACKGROUND

• Chastanet S, Pittaluga P. Influence of the competence of the sapheno-femoral junction on the mode of treatment of varicose veins by surgery. Phlebology. 2014 May;29(1 suppl):61-65. doi: 10.1177/0268355514529207. Epub 2014 May 19.

  PMID: 24843088 BACKGROUND

• van Neer P, Kessels FG, Estourgie RJ, de Haan EF, Neumann MA, Veraart JC. Persistent reflux below the knee after stripping of the great saphenous vein. J Vasc Surg. 2009 Oct;50(4):831-4. doi: 10.1016/j.jvs.2009.05.021. Epub 2009 Jul 12.

  PMID: 19595549 BACKGROUND

• Zolotukhin IA, Seliverstov EI, Zakharova EA, Kirienko AI. Short-term results of isolated phlebectomy with preservation of incompetent great saphenous vein (ASVAL procedure) in primary varicose veins disease. Phlebology. 2017 Oct;32(9):601-607. doi: 10.1177/0268355516674415. Epub 2016 Oct 19.

  PMID: 27760806 BACKGROUND

• Harlander-Locke M, Jimenez JC, Lawrence PF, Derubertis BG, Rigberg DA, Gelabert HA. Endovenous ablation with concomitant phlebectomy is a safe and effective method of treatment for symptomatic patients with axial reflux and large incompetent tributaries. J Vasc Surg. 2013 Jul;58(1):166-72. doi: 10.1016/j.jvs.2012.12.054. Epub 2013 Apr 6.

  PMID: 23571079 BACKGROUND

• Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P. Endovenous laser therapy and radiofrequency ablation of the great saphenous vein: analysis of early efficacy and complications. J Vasc Surg. 2005 Sep;42(3):488-93. doi: 10.1016/j.jvs.2005.05.014.

  PMID: 16171593 BACKGROUND

• Nesbitt C, Bedenis R, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database Syst Rev. 2014 Jul 30;(7):CD005624. doi: 10.1002/14651858.CD005624.pub3.

  PMID: 25075589 BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Genadz Kandratsenka, Prof

  Educational Institution"Belarusian State Medical University"

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 26, 2019
• Study Start: January 1, 2013
• Primary Completion: July 23, 2019
• Study Completion: February 1, 2025
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 01.2020
• Access Criteria: To compare clinical efficacy of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).

Locations

BE (1)