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

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

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).

Study Overview

• Status: Completed
• Conditions: Varicose Veins; Venous Insufficiency; Venous Reflux
• Intervention / Treatment: Other: Chart review

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 Type: Observational
• Enrollment (Actual): 547

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endovenous Thermal Ablation; Limbs treated with either radiofrequency ablation or endovenous laser ablation	Other: Chart review; Retrospective review of medical records at a single site with six physicians
Cyanoacrylate Closure; Limbs treated with cyanoacrylate closure system	Other: Chart review; Retrospective review of medical records at a single site with six physicians

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Disease	Assess potential change in clinical class using the Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class	At treatment through six months of index procedure
Severity of Disease	Assess potential change in clinical severity score using the Revised Venous Clinical Severity Score (rVCSS).	At treatment through six months of index procedure
Utilization of adjunctive treatments	Assess utilization of adjunctive sclerotherapy, either for cosmetic or medical need	Through six months of index procedure
Adverse events reported during clinic visits	If adverse events were reported and documented in chart, these will be collected and categorized to assess for comparison between groups	Though six months of index procedure

Collaborators and Investigators

• Sponsor: Lake Washington Vascular
• Collaborators: Medtronic
• Investigators: Principal Investigator: Kathleen D Gibson, MD, Lake Washington Vascular, PLLC

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: June 29, 2019
• First Submitted That Met QC Criteria: June 29, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Venaseal; Symptomatic Varicose Veins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency; Varicose Veins
• Other Study ID Numbers: GG2019/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No