Flush Versus Standard Distance From Saphenofemoral Junction in Endovenous Laser Ablation of Great Saphenous Vein

NCT06913322 | Completed Phase 4 DMC

• 2 other identifiers: KFSIRB200-278MUka12
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Varicose veins of the great saphenous vein (GSV) are a prevalent venous disorder, with higher incidence in women. They cause swelling, pain, ulcers, eczema, and phlebitis, impacting patients' occupational performance and quality of life. Endovenous laser ablation (EVLA) has been supplanted by high-level laser surgery (HLS) as the primary treatment for incompetent GSVs. EVLA uses laser energy to generate heat, altering or inactivating proteins and enzymes within the vessel wall. Occlusion rates are shown to be around 95% after one year. However, the influence of the untreated proximal segment adjacent to the sapheno-femoral junction (SFJ) on reflux and recurrence is ambiguous. Contemporary laser fibers, such as radially emitting fibers, can reduce postoperative discomfort and improve outcomes. However, data on the safety and long-term outcomes of flush ablation compared to standard ablation remains insufficient.

Conditions

Varicose Veins Leg

Keywords

laser ablation; flush; standard distance

Outcome Measures

Primary Outcomes (2)

• occlusion rate

  1-percentage of treated veins that remain closed or occluded (blocked) following the EVLA. It is an important measure of the treatment's effectiveness in permanently sealing the vein, preventing blood flow through ablated area.

  1 year

• endovenous heat induced thrombosis

  formation of a blood clot at saphenofemoral junction caused by heat from endovenous laser ablation of great saphenous vein

  1 year

Secondary Outcomes (1)

• complications

  1 year

Study Arms (2)

flush EVLA

ACTIVE COMPARATOR

The fiber tip was positioned in fEVLA group Flush at SFJ

Procedure: flush endovenous laser ablation of great saphenous vein

standard EVLA

ACTIVE COMPARATOR

The fiber tip was positioned in sEVLA group 2 cm distal to SFJ

Procedure: standard endovenous laser ablation of great saphenous vein

Interventions

flush endovenous laser ablation of great saphenous vein PROCEDURE

A 4 French sheath is advanced over the wire and positioned in the great saphenous vein below knee. Diode laser (SmartM; Lasotronix) with a 600-mm radial fiber catheter was used. The tip of the laser was be placed flush at saphenofemoral junction.

flush EVLA

standard endovenous laser ablation of great saphenous vein PROCEDURE

A 4 French sheath is advanced over the wire and positioned in the great saphenous vein below knee. Diode laser (SmartM; Lasotronix) with a 600-mm radial fiber catheter was used. The tip of the laser was be placed 2 cm distal to saphenofemoral junction.

standard EVLA

Eligibility Criteria

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

You may qualify if:

• age 18-60 years.
• patients with CEAP classes C2 to C6
• primary great saphenous vein insufficiency with at least 0.5 seconds of reflux in the standing position on color Doppler ultrasound.

You may not qualify if:

• deep or superficial venous thrombosis
• previous treatment of the varicose veins
• severe infection in the ipsilateral lower limb
• GSV diameter more than15 mm or less than 3 mm
• ipsilateral lower limb arterial stenosis or occlusion;
• pregnancy or breastfeeding;
• iliac vein compression syndrome.
• congenital venous anomalies
• allergy to lidocaine
• Debilitating systemic disease.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafrelsheikh, Kafrelsheikh, 08532, Egypt

Location

Related Publications (15)

• Gauw SA, Lawson JA, van Vlijmen-van Keulen CJ, Pronk P, Gaastra MT, Mooij MC. Five-year follow-up of a randomized, controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anesthesia. J Vasc Surg. 2016 Feb;63(2):420-8. doi: 10.1016/j.jvs.2015.08.084. Epub 2015 Oct 23.

  PMID: 26602795 BACKGROUND

• Hirokawa M, Ogawa T, Sugawara H, Shokoku S, Sato S. Comparison of 1470 nm Laser and Radial 2ring Fiber with 980 nm Laser and Bare-Tip Fiber in Endovenous Laser Ablation of Saphenous Varicose Veins: A Multicenter, Prospective, Randomized, Non-Blind Study. Ann Vasc Dis. 2015;8(4):282-9. doi: 10.3400/avd.oa.15-00084. Epub 2015 Sep 9.

  PMID: 26730252 BACKGROUND

• Pannier F, Rabe E, Rits J, Kadiss A, Maurins U. Endovenous laser ablation of great saphenous veins using a 1470 nm diode laser and the radial fibre--follow-up after six months. Phlebology. 2011 Feb;26(1):35-9. doi: 10.1258/phleb.2010.009096. Epub 2010 Dec 9.

  PMID: 21148467 BACKGROUND

• Doganci S, Demirkilic U. Comparison of 980 nm laser and bare-tip fibre with 1470 nm laser and radial fibre in the treatment of great saphenous vein varicosities: a prospective randomised clinical trial. Eur J Vasc Endovasc Surg. 2010 Aug;40(2):254-9. doi: 10.1016/j.ejvs.2010.04.006. Epub 2010 May 23.

  PMID: 20547079 BACKGROUND

• Theivacumar NS, Darwood R, Gough MJ. Neovascularisation and recurrence 2 years after varicose vein treatment for sapheno-femoral and great saphenous vein reflux: a comparison of surgery and endovenous laser ablation. Eur J Vasc Endovasc Surg. 2009 Aug;38(2):203-7. doi: 10.1016/j.ejvs.2009.03.031. Epub 2009 Jun 12.

  PMID: 19524460 BACKGROUND

• O'Donnell TF, Balk EM, Dermody M, Tangney E, Iafrati MD. Recurrence of varicose veins after endovenous ablation of the great saphenous vein in randomized trials. J Vasc Surg Venous Lymphat Disord. 2016 Jan;4(1):97-105. doi: 10.1016/j.jvsv.2014.11.004. Epub 2015 Apr 11.

  PMID: 26946904 BACKGROUND

• Rass K, Frings N, Glowacki P, Graber S, Tilgen W, Vogt T. Same Site Recurrence is More Frequent After Endovenous Laser Ablation Compared with High Ligation and Stripping of the Great Saphenous Vein: 5 year Results of a Randomized Clinical Trial (RELACS Study). Eur J Vasc Endovasc Surg. 2015 Nov;50(5):648-56. doi: 10.1016/j.ejvs.2015.07.020. Epub 2015 Aug 28.

  PMID: 26319476 BACKGROUND

• Flessenkamper I, Hartmann M, Hartmann K, Stenger D, Roll S. Endovenous laser ablation with and without high ligation compared to high ligation and stripping for treatment of great saphenous varicose veins: Results of a multicentre randomised controlled trial with up to 6 years follow-up. Phlebology. 2016 Feb;31(1):23-33. doi: 10.1177/0268355514555547. Epub 2014 Oct 22.

  PMID: 25342648 BACKGROUND

• Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL. Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction. Eur J Vasc Endovasc Surg. 2011 May;41(5):685-90. doi: 10.1016/j.ejvs.2010.12.014. Epub 2011 Feb 18.

  PMID: 21333560 BACKGROUND

• Pannier F, Rabe E, Maurins U. First results with a new 1470-nm diode laser for endovenous ablation of incompetent saphenous veins. Phlebology. 2009 Feb;24(1):26-30. doi: 10.1258/phleb.2008.008038.

  PMID: 19155338 BACKGROUND

• Lawaetz M, Serup J, Lawaetz B, Bjoern L, Blemings A, Eklof B, Rasmussen L. Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT. Int Angiol. 2017 Jun;36(3):281-288. doi: 10.23736/S0392-9590.17.03827-5. Epub 2017 Feb 17.

  PMID: 28217989 BACKGROUND

• Castro-Ferreira R, Quelhas MJ, Freitas A, Vidoedo J, Silva EA, Marinho A, Abreu R, Coelho A, Dias PG, Sampaio SM. Vascular training does matter in the outcomes of saphenous high ligation and stripping. J Vasc Surg Venous Lymphat Disord. 2019 Sep;7(5):732-738. doi: 10.1016/j.jvsv.2019.01.060. Epub 2019 May 5.

  PMID: 31068278 BACKGROUND

• Carroll C, Hummel S, Leaviss J, Ren S, Stevens JW, Everson-Hock E, Cantrell A, Stevenson M, Michaels J. Clinical effectiveness and cost-effectiveness of minimally invasive techniques to manage varicose veins: a systematic review and economic evaluation. Health Technol Assess. 2013 Oct;17(48):i-xvi, 1-141. doi: 10.3310/hta17480.

  PMID: 24176098 BACKGROUND

• Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011 Apr;98(4):501-10. doi: 10.1002/bjs.7394. Epub 2011 Jan 31.

  PMID: 21283981 BACKGROUND

• Tauraginskii RA, Lurie F, Agalarov R, Simakov S, Borsuk D. Blood flow from competent tributaries is likely contributor to distally increasing reflux volume in incompetent great saphenous vein. J Vasc Surg Venous Lymphat Disord. 2022 Jan;10(1):69-74. doi: 10.1016/j.jvsv.2021.04.010. Epub 2021 May 4.

  PMID: 33957280 BACKGROUND

MeSH Terms

Conditions

Blushing

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: endovenous laser ablation of lower limb varicose veins

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 6, 2025
• Study Start: January 21, 2024
• Primary Completion: February 20, 2025
• Study Completion: March 20, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-03

Locations

EG (1)