VenaSeal for Venous Reflux Disease

Recruiting at 41 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the most effective treatment for venous reflux disease, a condition where blood flows backward in the veins, causing symptoms like swelling and pain. It compares the VenaSeal™ Closure System, which uses a special glue to close affected veins, with two other treatments: endothermal ablation (using heat) and surgical stripping (removing the vein). Candidates include those with noticeable symptoms of venous reflux and veins at least 10 cm long and 3 mm wide. The goal is to identify the method that is most effective and easiest for patients to handle. As an unphased trial, this study provides a unique opportunity for patients to explore different treatment options and contribute to medical knowledge.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the VenaSeal™ Closure System is generally safe and effective. One study found that after three years, 94.4% of patients achieved successful vein closure with VenaSeal, which is very promising. Another study indicated that 9 out of 10 patients would choose the VenaSeal procedure again, reflecting a positive overall experience. Additionally, other studies have confirmed that the VenaSeal system meets safety standards, ensuring the treatment's reliability.

For Endothermal Ablation (ETA), research often shows it is a common and safe treatment for vein problems. Mild side effects like bruising or swelling may occur, but these usually resolve quickly.

When considering these treatments, existing data supports their safety. It is always important to discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the VenaSeal™ Closure System for treating venous reflux disease because it offers a unique, non-thermal, non-tumescent approach to vein closure. Unlike standard treatments like endothermal ablation (ETA) and surgical stripping, which use heat or invasive methods to seal veins, VenaSeal™ uses a medical adhesive to close the affected veins. This method potentially reduces discomfort, eliminates the need for anesthesia, and decreases recovery time. Additionally, VenaSeal™ may result in fewer complications, making it a promising alternative to traditional treatments.

What evidence suggests that this trial's treatments could be effective for venous reflux disease?

Research has shown that the VenaSeal™ Closure System effectively treats venous reflux disease. In one study, researchers observed patients for three years, and 94.4% of the veins treated with VenaSeal remained closed, demonstrating strong and lasting results. Another study found that VenaSeal led to fewer complications, such as infections, compared to other treatments. Patients required fewer repeat procedures, indicating effective initial treatment for most individuals. In this trial, participants will be randomized to receive either the VenaSeal™ System or other treatments, such as Endothermal Ablation (ETA) or Surgical Stripping. These findings suggest that VenaSeal is a promising option for managing venous reflux disease. ^{2 3 6 7 8}

Who Is on the Research Team?

Kathleen Gibson, MD

Principal Investigator

Lake Washington Vascular, US

Manjit Gohel, MD

Principal Investigator

Addenbrooke's Hospital, UK

Are You a Good Fit for This Trial?

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.

Eligibility for treatment:

Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Single arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System Experimental Treatment 1 Intervention

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

Group II: Randomized study VenaSeal™ System versus Surgical Stripping: VenaSeal™ System Experimental Treatment 1 Intervention

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

Group III: Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): VenaSeal™ System Experimental Treatment 1 Intervention

CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA

Group IV: Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): ETA Active Control 1 Intervention

CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA

Group V: Randomized study VenaSeal™ System versus Surgical Stripping: Surgical Stripping Active Control 1 Intervention

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

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38676860/

3-year clinical outcomes of A Singapore VenaSeal™ real ... Conclusion: The 3-year follow-up results of the ASVS registry demonstrated continued and sustained clinical efficacy with few reinterventions ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11055841/

3-year clinical outcomes of A Singapore VenaSeal™ real ... The 3-year follow-up results of the ASVS registry demonstrated continued and sustained clinical efficacy with few reinterventions following CAG embolization.

3. evtoday.com evtoday.com/news/three-year-veclose-data-and-1-year-waves-data-presented-for-medtronics-venaseal-closure-system

Three-Year VeClose Data and 1-Year WAVES Data ... At 3 years, complete closure of the GSV was achieved in 94.4% of patients treated with VenaSeal compared to 91.9% of patients treated with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X19307024

Network meta-analysis to compare VenaSeal with other ... VenaSeal system is a promising therapeutic option for anatomic success at 6 months, with fewer occurrences of adverse events (wound and groin infection, ...

5. journals.lww.com journals.lww.com/tmj/fulltext/2023/17020/use_of_the_venaseal_closure_system_for_the.4.aspx

Use of the VenaSeal closure system for the treatment of... This retrospective clinical study used data from 19 patients who received the VenaSeal Closure System for venous reflux disease from October 2019 to December ...

6. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiovascular/superficial-vein/venaseal-closure-system/clinical-evidence.html

Clinical Evidence - Venaseal™ Closure System Great outcomes · 75% improvement in VCSS scores at five years · 94.6% closure rate at five years · 9 of 10 patients would choose VenaSeal™ procedure again at five ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949912724000722

Study design of the VenaSeal Spectrum Program: Two ... In a retrospective study of patients with VLUs, VenaSeal showed a significantly shorter time to ulcer wound healing compared with RFA, which the authors ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140018b.pdf

summary of safety and effectiveness data (ssed) The non-clinical studies indicate that the VenaSeal Closure System meets or exceeds safety and performance specifications. Data from non ...