Phase 4
N=200
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
Chronic Venous Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT02236338 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. — 79.3; 77.5 percentage of total participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ablation of the Incompetent Greater Saphenous Vein (Procedure); ClosureFAST radiofrequency catheter (Device); EVLT 980nm diode laser system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. |
79.3; 77.5 | — |
| SECONDARY Incidence Rate of Acute Complications |
0; 0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02236338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.