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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovenous Thermal Ablation | Limbs treated with either radiofrequency ablation or endovenous laser ablation |
| |
| Cyanoacrylate Closure | Limbs treated with cyanoacrylate closure system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chart review | Other | Retrospective review of medical records at a single site with six physicians |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjunctive phlebectomy | Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure | Through 6 months of index procedure |
| Cost of Treatment | A cost analysis will be performed calculating the total cost of treatment between groups | Through six months of index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Disease | Assess potential change in clinical class using the Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class | At treatment through six months of index procedure |
| Severity of Disease |
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Inclusion Criteria:
Limb with saphenous vein incompetence, treated with one of the following:
VenaSeal â„¢ Endovenous Laser Ablation Radiofrequency Ablation
CEAP Clinical Class between 2-5
Limb treated from October 1st, 2015-present
At least 2 months of follow-up post index procedure
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:
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327 limbs treated with Cyanoacrylate Closure and 327 limbs treated with Endovenous Thermal Ablation for symptomatic varicose veins and incompetence of the great or small saphenous vein, or both veins.
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen D Gibson, MD | Lake Washington Vascular, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lake Washington Vascular, PLLC | Bellevue | Washington | 98004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42267768 | Derived | Gibson K, Glorieux K, Minjarez R, Foster E, Neradilek M, Polissar N. Adjunctive procedure utilization and cost comparison of cyanoacrylate versus endothermal ablation for saphenous vein reflux. Vasc Med. 2026 Jun;31(3):360-368. doi: 10.1177/1358863X261434818. Epub 2026 Jun 10. |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Assess potential change in clinical severity score using the Revised Venous Clinical Severity Score (rVCSS).
| At treatment through six months of index procedure |
| Utilization of adjunctive treatments | Assess utilization of adjunctive sclerotherapy, either for cosmetic or medical need | 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 | Though six months of index procedure |