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

Varicose Veins Clinical Trial

— VALUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006184
• Other study ID #: GG2019/01
• Status: Completed
• Start date: June 14, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: October 2019
• Source: Lake Washington Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) -

Related Conditions & MeSH terms

• Varicose Veins
• Venous Insufficiency
• Venous Reflux

Intervention

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

Locations

Country	Name	City	State
United States	Lake Washington Vascular, PLLC	Bellevue	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Lake Washington Vascular	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjunctive phlebectomy	Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure	Through 6 months of index procedure
Primary	Cost of Treatment	A cost analysis will be performed calculating the total cost of treatment between groups	Through six months of index procedure
Secondary	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
Secondary	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
Secondary	Utilization of adjunctive treatments	Assess utilization of adjunctive sclerotherapy, either for cosmetic or medical need	Through six months of index procedure
Secondary	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