Retrospective Review of Saphenous Vein Incompetence: Venaseal Versus Endovenous Thermal Ablation

Lake Washington Vascular547 enrolled

Overview

This study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. Treated limbs must have the Great Saphenous Vein and/or Small Saphenous Vein treated with either cyanoacrylate closure (VenaSeal) or Endothermal Ablation (either Radiofrequency Ablation or Endovenous Laser Ablation).

This single site, retrospective, comparison study aims to review up to 400 treated limbs with symptomatic varicose veins to compare the need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure in conjunction with either cyanoacrylate closure versus endothermal ablation of incompetent saphenous veins through 6 months of the index procedure. The overall cost of treatment for both groups will be compared. Some of the secondary aims of this study include: 1. To assess changes in Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class after completion of treatment. 2. To assess changes in revised Venous Clinical Severity Score (rVCSS) and compare the two groups. 3. To assess the need for adjunctive therapies. 4. To record and compare retrospectively the adverse events between the two groups.

Study Type

OBSERVATIONAL

Enrollment

547

Conditions

Varicose Veins Venous Reflux Venous Insufficiency

Interventions

Chart reviewOTHER

Retrospective review of medical records at a single site with six physicians

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Limb with saphenous vein incompetence, treated with one of the following: VenaSeal ™ Endovenous Laser Ablation Radiofrequency Ablation 2. CEAP Clinical Class between 2-5 3. Limb treated from October 1st, 2015-present 4. At least 2 months of follow-up post index procedure 5. Treatment of either the great saphenous vein (GSV), the small saphenous vein (SSV), or both. Treatment of accessory saphenous veins (ASV) is allowed as long as either the GSV, SSV, or both the GSV and SSV were treated as well in that limb at the index procedure. Exclusion Criteria: 1. Limb treatment of the accessory saphenous vein (ASV) without concomitant great saphenous vein (GSV) and/or small saphenous vein (SSV) treatment 2. Limb treatment for reasons other than symptomatic varicose veins 3. Limbs without follow-up information at least 2 months following the index procedure 4. Subjects who participated in another clinical trial as part of their saphenous vein treatment 5. Investigator decision (concurrent condition that would make inclusion inappropriate, protected subject population) -

Locations (1)

Lake Washington Vascular, PLLC

Bellevue, Washington, United States

Outcomes

Primary Outcomes

Adjunctive phlebectomy

Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure

Time frame: Through 6 months of index procedure

Cost of Treatment

A cost analysis will be performed calculating the total cost of treatment between groups

Time frame: Through six months of index procedure

Secondary Outcomes

Severity of Disease

Assess potential change in clinical class using the Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class

Time frame: At treatment through six months of index procedure

Severity of Disease

Assess potential change in clinical severity score using the Revised Venous Clinical Severity Score (rVCSS).

Time frame: At treatment through six months of index procedure

Utilization of adjunctive treatments

Assess utilization of adjunctive sclerotherapy, either for cosmetic or medical need

Time frame: Through six months of index procedure

Adverse events reported during clinic visits

If adverse events were reported and documented in chart, these will be collected and categorized to assess for comparison between groups

Time frame: Though six months of index procedure

Data from ClinicalTrials.gov

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