Clinical Trial of Endovenous 940 and 1470 Laser Ablation for Treating Great Saphenous Veins (COLA)

Comparative Randomized Clinical Trial of Endovenous 940 nm Laser Ablation Versus Endovenous 1470 nm Laser Ablation for Treatment of Great Saphenous Veins

A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.

Study Overview

• Status: Completed
• Conditions: Varicose Veins; Insufficiency of Great Saphenous Vein
• Intervention / Treatment: Procedure: Endovenous laser ablation (EVLA)

Detailed Description

* Study type: Interventional. Randomized comparative clinical trial..

• Outcome measures:

  • Primary study outcomes: Patient reported outcomes: 1. Pain score and use of painkillers, assessed with a numeric rating scale (NRS) of pain. 2. Treatment satisfaction, assessed with a NRS of satisfaction. 3. Health related quality of life, assessed with Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire.
  • Secondary study outcomes: 1. Number of patients with adverse events. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. Minor complications: ecchymosis and hyperpigmentation. 2. Obliteration of varicose vein and/or absence of reflux (> 0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.
• Outcome measures time frame:

Follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment.

* Focus of the study: Varicose great saphenous veins (GSV)

• Intervention information:

  • Intervention name: endovenous laser ablation (EVLA)
  • Intervention type: 1. EVLA with 940 nm Diode laser 2. EVLA with 1470 nm Nd:Yag laser
  • Arm information: both interventions are active comparators.
• Locations:

Rotterdam, Zuid-Holland, The Netherlands

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015 CA
    • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients over 18 years old
• Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 sec, and diameter of vein > 0.5 cm
• Symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ C2)
• No prior treatment of the insufficient GSV
• Informed consent

Exclusion Criteria:

• Acute deep or superficial vein thrombosis
• Agenesis of deep vein system
• Vascular malformation or syndrome
• Post-thrombotic syndrome, occlusive type
• Pregnancy
• Immobility
• Allergy to lidocaine
• Arterial insufficiency
• Diameter of GSV ≤ 0.5 mm at puncture site

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EVLA 940 nm	Procedure: Endovenous laser ablation (EVLA); EVLA with 940 nm Diode laser EVLA with 1470 nm Nd:Yag laser With both devices, obliteration of the varicose vein is obtained by heating the vein, using emission of laser light.
Active Comparator: EVLA 1470 nm	Procedure: Endovenous laser ablation (EVLA); EVLA with 940 nm Diode laser EVLA with 1470 nm Nd:Yag laser With both devices, obliteration of the varicose vein is obtained by heating the vein, using emission of laser light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score and use of painkillers	A questionnaire including a numeric rating scale (NRS) of pain is filled in by the patient.	1 week post treatment
Treatment satisfaction	A NRS of satisfaction is filled in by the patient.	1 week post treatment
Health related quality of life	Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire are filled in by the patient.	0 and 12 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Minor complications: ecchymoses and hyperpigmentation. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.	The adverse events will be assessed at 1 and 12 weeks post treatment.
Occlusion of the treated GSV (effectiveness)	Obliteration of varicose vein and/or absence of reflux (>0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.	The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment.

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Publications and helpful links

General Publications

• Malskat WS, Giang J, De Maeseneer MG, Nijsten TE, van den Bos RR. Randomized clinical trial of 940- versus 1470-nm endovenous laser ablation for great saphenous vein incompetence. Br J Surg. 2016 Feb;103(3):192-8. doi: 10.1002/bjs.10035. Epub 2015 Dec 14.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): February 11, 2015
• Last Update Submitted That Met QC Criteria: February 10, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: NL38160.078.11