Clinical trial NCT02248740: Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein
Official title: Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Venous Insufficiency
Keywords: chronic venous insufficiency
varicose vein
small saphenous vein
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.
timeFrame: At 10 years after treatment.
Secondary outcomes:
measure: Incidence Rate of Acute Complications
timeFrame: 1 and 6 weeks post intervention.
Other outcomes:
measure: Incidence of Pain and Bruising
timeFrame: During Intervention and post procedure recovery period in clinic, an expected average of 2 hours.
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Malcolm Sydnor, MD
role: PRINCIPAL_INVESTIGATOR
References: