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Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein

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ClinicalTrials.gov Identifier: NCT02236338
Recruitment Status : Completed
First Posted : September 10, 2014
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Procedure: Ablation of the Incompetent Greater Saphenous Vein Device: ClosureFAST radiofrequency catheter Device: EVLT 980nm diode laser system Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein: A Prospective Randomized Trial
Study Start Date : September 2008
Actual Primary Completion Date : August 11, 2016
Actual Study Completion Date : August 11, 2016

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



Primary Outcome Measures :
  1. Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. [ Time Frame: Annual follow up, up to 75 months ]

Secondary Outcome Measures :
  1. Incidence Rate of Acute Complications [ Time Frame: up to 6 weeks post intervention ]
    Number of acute complications at one and 6 weeks post intervention


Other Outcome Measures:
  1. Incidence of Post-procedure Pain [ Time Frame: During post procedure recovery period in clinic, an expected average of 2 hours after surgery. ]
    Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.

  2. Incidence of Objective Post-procedure Bruising [ Time Frame: During post procedure recovery period in clinic, an expected average of 2 hours after surgery. ]
    Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236338


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Malcolm Sydnor, MD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02236338     History of Changes
Other Study ID Numbers: HM11792
First Posted: September 10, 2014    Key Record Dates
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018
Last Verified: April 2018
Keywords provided by Virginia Commonwealth University:
chronic venous insufficiency
varicose vein
greater saphenous vein
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases