Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein

Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small 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 related to the Small Saphenous Vein (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.

Study Overview

• Status: Terminated
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Procedure: Ablation of the incompetent small saphenous vein

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 second most common cause is a refluxing or incompetent Small Saphenous Vein (SSV). 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 SSV 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 SSV 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): 36
• 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 indicated.
• Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).
• Have symptoms secondary to Small 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 Deep Venous Thrombosis (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 small saphenous vein, using this device.	Procedure: Ablation of the incompetent small saphenous vein; For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
Active Comparator: Laser Ablation; Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.	Procedure: Ablation of the incompetent small saphenous vein; For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.	At 10 years after treatment.

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence Rate of Acute Complications	1 and 6 weeks post intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pain and Bruising	Measurement of pain will be performed by patient solicitation of pain rating on a scale of 0 to 10. Bruising will be measured on a scale of 0-10, determined by a consensus of all study investigators.	During Intervention and post procedure recovery period in clinic, an expected average of 2 hours.

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): March 29, 2017
• Study Completion (Actual): March 29, 2017

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 22, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: varicose vein; chronic venous insufficiency; small saphenous vein
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: HM11844