Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236338
• Other study ID #: HM11792
• Status: Completed
• Phase: Phase 4
• Start date: September 2008
• Est. completion date: August 11, 2016

Study information

• Verified date: April 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 11, 2016
• Est. primary completion date: August 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

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

• EVLT 980nm diode laser system

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.		Annual follow up, up to 75 months
Secondary	Incidence Rate of Acute Complications	Number of acute complications at one and 6 weeks post intervention	up to 6 weeks post intervention