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

NCT04006184 | Completed

• 1 other identifier: GG2019/01
• Study Type: observational
• Target: 547
• Locations: 1 country
• Sites: 1

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).

Conditions

Varicose Veins; Venous Reflux; Venous Insufficiency

Keywords

Venaseal; Symptomatic Varicose Veins

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Severity of Disease

  At treatment through six months of index procedure

• Severity of Disease

  At treatment through six months of index procedure

• Utilization of adjunctive treatments

  Through six months of index procedure

• Adverse events reported during clinic visits

  Though six months of index procedure

Study Arms (2)

Endovenous Thermal Ablation

Limbs treated with either radiofrequency ablation or endovenous laser ablation

Other: Chart review

Cyanoacrylate Closure

Limbs treated with cyanoacrylate closure system

Other: Chart review

Interventions

Chart review OTHER

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

Cyanoacrylate Closure; Endovenous Thermal Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lake Washington Vascular: lead
• Medtronic: collaborator

Study Sites (1)

Lake Washington Vascular, PLLC

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Varicose Veins; Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kathleen D Gibson, MD

  Lake Washington Vascular, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 5, 2019
• Study Start: June 14, 2019
• Primary Completion: July 30, 2019
• Study Completion: August 30, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)