Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein

Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein: A Prospective Randomized Trial

The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency, in an effort to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Procedure: Ablation of the Incompetent Greater Saphenous Vein; Device: ClosureFAST radiofrequency catheter; Device: EVLT 980nm diode laser system

Detailed Description

Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in the lower extremities. The most common cause is a refluxing or incompetent Greater Saphenous Vein (GSV). This condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. The historical treatment has been to surgically remove or 'strip' the GSV so that blood is rerouted through the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This involves advancing a catheter under ultrasound guidance through the GSV and then advancing a laser fiber or radiofrequency probe through the catheter. These devices then produce the energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. This is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. The aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

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 with symptomatic chronic venous insufficiency.
• Patients in whom endovenous thermal ablation is clinically indicate.
• Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).
• Have venous disease that meets CEAP clinical class 2 through 6.
• Have symptoms secondary to Greater Saphenous Vein insufficiency defined as reverse flow in the saphenous vein >0.5 seconds after calf compression or while standing.

Exclusion Criteria:

• Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures).
• Have a history of DVT.
• Have a history of hypercoaguability disorder.
• Are pregnant or breastfeeding.
• Are nonambulatory.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiofrequency Ablation; Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.	Procedure: Ablation of the Incompetent Greater Saphenous Vein; For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.; Device: ClosureFAST radiofrequency catheter
Active Comparator: Laser Ablation; Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.	Procedure: Ablation of the Incompetent Greater Saphenous Vein; For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.; Device: EVLT 980nm diode laser system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.	Annual follow up, up to 75 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of Acute Complications	Number of acute complications at one and 6 weeks post intervention	up to 6 weeks post intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post-procedure Pain	Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.	During post procedure recovery period in clinic, an expected average of 2 hours after surgery.
Incidence of Objective Post-procedure Bruising	Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.	During post procedure recovery period in clinic, an expected average of 2 hours after surgery.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Malcolm Sydnor, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 11, 2016
• Study Completion (Actual): August 11, 2016

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: varicose vein; chronic venous insufficiency; greater saphenous vein
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: HM11792