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

Lake Washington Vascular

Status: Completed

Conditions: Venous Insufficiency; Venous Reflux; Varicose Veins

Treatments: Other: Chart review

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04006184

GG2019/01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 547 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) -

Trial design

547 participants in 2 patient groups

Endovenous Thermal Ablation

Description:

Limbs treated with either radiofrequency ablation or endovenous laser ablation

Treatment:

Other: Chart review

Cyanoacrylate Closure

Description:

Limbs treated with cyanoacrylate closure system

Treatment:

Other: Chart review