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

Overview

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 Title of Study: “Venaseal Versus Ablation With Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 30, 2019

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

  • Other: Chart review
    • Retrospective review of medical records at a single site with six physicians

Arms, Groups and Cohorts

  • Endovenous Thermal Ablation
    • Limbs treated with either radiofrequency ablation or endovenous laser ablation
  • Cyanoacrylate Closure
    • Limbs treated with cyanoacrylate closure system

Clinical Trial Outcome Measures

Primary Measures

  • Adjunctive phlebectomy
    • Time Frame: Through 6 months of index procedure
    • Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure
  • Cost of Treatment
    • Time Frame: Through six months of index procedure
    • A cost analysis will be performed calculating the total cost of treatment between groups

Secondary Measures

  • Severity of Disease
    • Time Frame: At treatment through six months of index procedure
    • Assess potential change in clinical class using the Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class
  • Severity of Disease
    • Time Frame: 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
    • Time Frame: Through six months of index procedure
    • Assess utilization of adjunctive sclerotherapy, either for cosmetic or medical need
  • Adverse events reported during clinic visits
    • Time Frame: 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

Participating in This Clinical Trial

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) -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lake Washington Vascular
  • Collaborator
    • Medtronic
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kathleen D Gibson, MD, Principal Investigator, Lake Washington Vascular, PLLC

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.