Varicose Veins, Venous Insufficiency, Venous Reflux
Conditions
Keywords
Venaseal, Symptomatic Varicose Veins
Brief summary
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).
Detailed description
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.
Interventions
OTHERChart review
Retrospective review of medical records at a single site with six physicians
Sponsors
Medtronic
Lake Washington Vascular
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjunctive phlebectomy | Through 6 months of index procedure | Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure |
| Cost of Treatment | Through six months of index procedure | A cost analysis will be performed calculating the total cost of treatment between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Disease | At treatment through six months of index procedure | Assess potential change in clinical class using the Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class |
| Utilization of adjunctive treatments | Through six months of index procedure | Assess utilization of adjunctive sclerotherapy, either for cosmetic or medical need |
| Adverse events reported during clinic visits | Though six months of index procedure | If adverse events were reported and documented in chart, these will be collected and categorized to assess for comparison between groups |
Countries
United States
Outcome results
None listed