Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein

Phase 4

Completed

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

• Registration Number: NCT02236338
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-10
• Primary Completion: 2016-08-11
• Study Completion: 2016-08-11
• Results First Submitted: 2018-01-31
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-11
• Last Update Submitted: 2018-04-11
• Results First Posted: 2018-05-14
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency Ablation	ClosureFAST radiofrequency catheter	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.
Radiofrequency Ablation	Ablation of the Incompetent Greater Saphenous Vein	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.
Laser Ablation	Ablation of the Incompetent Greater Saphenous Vein	Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.
Laser Ablation	EVLT 980nm diode laser system	Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence Rate of Acute Complications	up to 6 weeks post intervention	Number of acute complications at one and 6 weeks post intervention

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States