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Completed

NCT Number: NCT04006184

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

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).

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases Venous Insufficiency Venous Reflux

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lake Washington Vascular, PLLC

Bellevue, Washington, 98004, United States

About this study

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:

  • To assess changes in Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class after completion of treatment.
  • To assess changes in revised Venous Clinical Severity Score (rVCSS) and compare the two groups.
  • To assess the need for adjunctive therapies.
  • To record and compare retrospectively the adverse events between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Limb with saphenous vein incompetence, treated with one of the following:

VenaSeal ™ 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

  • Limb treatment of the accessory saphenous vein (ASV) without concomitant great saphenous vein (GSV) and/or small saphenous vein (SSV) treatment
  • Limb treatment for reasons other than symptomatic varicose veins
  • Limbs without follow-up information at least 2 months following the index procedure
  • Subjects who participated in another clinical trial as part of their saphenous vein treatment
  • Investigator decision (concurrent condition that would make inclusion inappropriate, protected subject population) -

Treatment and study plan

Chart review

Other

Retrospective review of medical records at a single site with six physicians

Primary outcomes

  1. Adjunctive phlebectomy

    Time frame: Through 6 months of index procedure

    Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure

  2. 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 outcomes

  1. 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

  2. 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).

  3. Utilization of adjunctive treatments

    Time frame: Through six months of index procedure

    Assess utilization of adjunctive sclerotherapy, either for cosmetic or medical need

  4. 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

Sponsors and collaborators

Lead sponsor

Lake Washington Vascular

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: VALUE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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