Clinical trial NCT04006184: Retrospective Review of Saphenous Vein Incompetence: Venaseal Versus Endovenous Thermal Ablation
Official title: Venaseal Versus Ablation With Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins
Venous Reflux
Venous Insufficiency
Keywords: Venaseal
Symptomatic Varicose Veins
Lead sponsor: Lake Washington Vascular
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-07-05
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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) -

Primary outcomes:
measure: Adjunctive phlebectomy
timeFrame: Through 6 months of index procedure
measure: Cost of Treatment
timeFrame: Through six months of index procedure
Secondary outcomes:
measure: Severity of Disease
timeFrame: At treatment through six months of index procedure
measure: Severity of Disease
timeFrame: At treatment through six months of index procedure
measure: Utilization of adjunctive treatments
timeFrame: Through six months of index procedure
measure: Adverse events reported during clinic visits
timeFrame: Though six months of index procedure
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Lake Washington Vascular, PLLC
state: Washington
Study officials:
affiliation: Lake Washington Vascular, PLLC
name: Kathleen D Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References: