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

NCT ID: NCT04006184

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 547 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-14
• Study Completion Date: 2019-08-30

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).

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.

Conditions

Varicose Veins; Venous Reflux; Venous Insufficiency

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Endovenous Thermal Ablation

Limbs treated with either radiofrequency ablation or endovenous laser ablation

Chart review

Intervention Type: OTHER

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

Cyanoacrylate Closure

Limbs treated with cyanoacrylate closure system

Chart review

Intervention Type: OTHER

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

Interventions

Chart review

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

Intervention Type: OTHER

Eligibility Criteria

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) -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Lake Washington Vascular

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen D Gibson, MD

Role: PRINCIPAL_INVESTIGATOR

Lake Washington Vascular, PLLC

Locations

Lake Washington Vascular, PLLC

Bellevue, Washington, United States

Countries

United States

Other Identifiers

GG2019/01

Identifier Type: -

Identifier Source: org_study_id