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

• Sponsor: Lake Washington Vascular (Other)
• Overall Status: Completed
• CT.gov ID: NCT04006184
• Collaborator: Medtronic (Industry)
• Enrollment: 547
• Location: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 216.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Varicose Veins; Venous Reflux; Venous Insufficiency	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 Design

• Study Type: Observational
• Actual Enrollment: 547 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Venaseal Versus Ablation With Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy
• Actual Study Start Date: Jun 14, 2019
• Actual Primary Completion Date: Jul 30, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Adjunctive phlebectomy [Through 6 months of index procedure]

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

2. Cost of Treatment [Through six months of index procedure]

   A cost analysis will be performed calculating the total cost of treatment between groups

Secondary Outcome Measures

1. Severity of Disease [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 [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 [Through six months of index procedure]

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

4. Adverse events reported during clinic visits [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

VenaSeal ™ Endovenous Laser Ablation Radiofrequency Ablation

1. CEAP Clinical Class between 2-5

2. Limb treated from October 1st, 2015-present

3. At least 2 months of follow-up post index procedure

4. 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) -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lake Washington Vascular, PLLC	Bellevue	Washington	United States	98004

Sponsors and Collaborators

• Lake Washington Vascular
• Medtronic

Investigators

• Principal Investigator: Kathleen D Gibson, MD, Lake Washington Vascular, PLLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lake Washington Vascular
• ClinicalTrials.gov Identifier: NCT04006184
• Other Study ID Numbers: GG2019/01
• First Posted: Jul 5, 2019
• Last Update Posted: Oct 3, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lake Washington Vascular: Venaseal; Symptomatic Varicose Veins
• Additional relevant MeSH terms: Venous Insufficiency; Varicose Veins

Study Results

No Results Posted as of Oct 3, 2019