VenaSeal for Venous Reflux Disease

Recruiting at 34 trial locations

Overseen By Analyn Jackson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Endovascular

Disqualifiers: Allergies, Deep vein obstruction, Thrombophlebitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: Index procedure

506 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the VenaSeal™ Closure System, which uses a special glue to close off problematic veins. It targets patients with superficial venous disease and those with active venous leg ulcers. The glue seals the vein, redirecting blood flow to healthier veins. The VenaSeal™ Closure System uses cyanoacrylate glue, which has been studied for its effectiveness in treating venous leg ulcers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

How does the VenaSeal treatment differ from other treatments for venous reflux disease?

The VenaSeal treatment is unique because it uses a special adhesive to close veins without the need for heat or injections of numbing fluid, making it less invasive than traditional methods like surgical stripping or endothermal ablation. ^{1 2 3 4 5}

Research Team

Kathleen Gibson, MD

Principal Investigator

Lake Washington Vascular, US

Manjit Gohel, MD

Principal Investigator

Addenbrooke's Hospital, UK

Eligibility Criteria

Adults over 18 with venous reflux in superficial veins, confirmed by ultrasound. They must have a vein diameter of at least 3mm and be able to follow the study's procedures. Pregnant or breastfeeding women, non-ambulatory individuals, those with certain health conditions like heart failure or severe liver dysfunction, or recent COVID-19 infection are excluded.

Inclusion Criteria

My target vein for treatment is 10 cm or longer.

I am 18 years old or older.

Eligibility for treatment:

Exclusion Criteria

IFU contraindications:

I cannot have surgical stripping or VenaSeal due to specific health reasons.

VLU Study: Patient has VenaSeal™ system IFU contraindication(s)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with VenaSeal™ Closure System, Surgical Stripping, or Endothermal Ablation (ETA) based on randomization

Index procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual) at 30 days, 6, and 12 months

Long-term Follow-up

Extended monitoring for anatomic closure and adverse events

60 months

Annual visits (in-person)

Treatment Details

Interventions

• Endothermal Ablation (ETA)
• Surgical Stripping
• VenaSeal™ Closure System

Trial Overview The trial compares the VenaSeal™ Closure System against traditional treatments for varicose veins: surgical stripping and endothermal ablation (ETA). It aims to determine which method is more effective for treating different stages of superficial venous disease.

Participant Groups

Group I: VenaSeal™ Closure System VLU Study Experimental Treatment 1 Intervention

CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System

Group II: VenaSeal™ Closure System Experimental Treatment 1 Intervention

CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping

Group III: Endothermal Ablation (ETA) Active Control 1 Intervention

CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA

Group IV: Surgical Stripping Active Control 1 Intervention

CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)

Who Is Running the Clinical Trial?

Medtronic Endovascular

Lead Sponsor

Trials

70

Recruited

15,000+

Geoff Martha

Medtronic Endovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Simona Zannetti

Medtronic Endovascular

Chief Medical Officer since 2024

MD from University of Perugia Medical School, research fellowship in vascular surgery at Massachusetts General Hospital, Harvard Medical School

References

1. England pubmed.ncbi.nlm.nih.gov

Predictive factors for changes in remnant stump length during and after the treatment of incompetent truncal saphenous veins using cyanoacrylate. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

VenaSeal closure despite allergic reaction to n-butyl cyanoacrylate. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Initial Outcomes of Cyanoacrylate Closure, VenaSeal System, for the Treatment of the Incompetent Great and Small Saphenous Veins. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

A multicenter randomized controlled trial of cyanoacrylate closure and surgical stripping for incompetent great saphenous veins. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Guidelines of the First International Consensus Conference on Endovenous Thermal Ablation for Varicose Vein Disease--ETAV Consensus Meeting 2012. [2022]