The purpose of this study is to demonstrate that patients will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of incompetent perforator veins (IPVs).
The purpose of this study is to demonstrate that patients who have competent great saphenous vein (GSV) and short saphenous vein (SSV) or have undergone prior successful endovenous treatment of an incompetent GSV and/or SSV but continue to demonstrate clinical symptoms of peripheral venous insufficiency resulting from incompetent perforator veins (IPVs) will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of IPVs veins.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Bipolar energy radiofrequency ablation with RFS stylet
Varicosity Vein Center
Birmingham, Alabama, United States
Vein Care Pavilion of the South
Evans, Georgia, United States
Allegiance Vascular Health
Jackson, Michigan, United States
Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.
QOL and clinical assessments measured by periodic CIVIQ2 and VCSS assessments were planned to be compared at each follow-up visit to pretreatment baseline. However, with the very low enrollment and limited data available, analysis and study results are inconclusive.
Time frame: 6 months
Cessation of Flow Through the Perforator Vein
Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.
Time frame: 6 months
CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)
CEAP Classification at Month 6 will be reported.
Time frame: 6 months
Cessation of Flow Reflux Through the Perforator Vein
Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.
Time frame: 6 months
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