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

Completed

• Conditions: Varicose Veins; Venous Reflux; Venous Insufficiency
• Interventions: Other: Chart review

• Registration Number: NCT04006184
• Lead Sponsor: Lake Washington Vascular

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.

Study Timeline

• Study Start: 2019-06-14
• Study First Submitted: 2019-06-29
• Study First Submitted QC: 2019-06-29
• Study First Posted: 2019-07-05
• Primary Completion: 2019-07-30
• Study Completion: 2019-08-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 547

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) -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endovenous Thermal Ablation	Chart review	Limbs treated with either radiofrequency ablation or endovenous laser ablation
Cyanoacrylate Closure	Chart review	Limbs treated with cyanoacrylate closure system

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Severity of Disease	At treatment through six months of index procedure	Assess potential change in clinical severity score using the Revised Venous Clinical Severity Score (rVCSS).
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

Trial Locations

Locations (1)

Lake Washington Vascular, PLLC; 🇺🇸 Bellevue, Washington, United States