Vascular Stent for Venous Obstruction

Recruiting at 21 trial locations

Overseen By Steven Abramowitz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Must not be taking: Antiplatelets, Thrombolytics, Anticoagulants, others

Disqualifiers: Pregnancy, Pulmonary embolism, Renal impairment, others

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 30 days

112 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a small tube called the GORE® VIAFORT Vascular Stent to help adults with blocked veins. The stent keeps the veins open so blood can flow properly.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to follow any required medication regimen, and you cannot have a known sensitivity or contraindication to antiplatelets, thrombolytics, or anticoagulants.

What data supports the effectiveness of the GORE® VIAFORT Vascular Stent treatment for venous obstruction?

Research on similar venous stents, like the VICI VENOUS STENT, shows they are effective in keeping veins open and improving symptoms in patients with venous obstruction. These stents have shown good clinical outcomes and safety in studies, suggesting that the GORE® VIAFORT Vascular Stent may also be effective for treating venous obstruction. ^{1 2 3 4 5}

Is the GORE® VIAFORT Vascular Stent safe for use in humans?

The GORE® Viabahn stent, a similar product, has been used safely in treating peripheral arterial disease, but there is limited long-term safety data. The Vici venous stent, another similar device, showed good safety outcomes in initial trials, though more long-term data is needed. ^{4 6 7 8 9}

How is the GORE® VIAFORT Vascular Stent treatment different from other treatments for venous obstruction?

The GORE® VIAFORT Vascular Stent is unique because it is specifically designed for venous applications, unlike many existing stents that were originally intended for arterial or biliary use. This design aims to provide the necessary flexibility and strength for treating venous obstructions effectively. ^{3 4 5 10 11}

Research Team

Kush Desai, MD

Principal Investigator

Northwestern University

Stephen Black, MD, FRCS (Ed), FEBVS

Principal Investigator

Guy's and St Thomas' NHS Foundation Trust

Eligibility Criteria

Adults over 18 with symptomatic vein blockages in the legs, able to follow treatment and check-up plans, not pregnant or planning pregnancy within a year. Excludes those with severe kidney issues, recent surgeries, significant blood clots in lungs, low hemoglobin levels, bleeding disorders, current participation in conflicting studies, major leg amputations, certain genetic conditions or drug sensitivities.

Inclusion Criteria

Patient is able to provide informed consent.

My vein condition is severe or causes me significant pain.

I am willing and able to follow all treatment and check-up plans.

Exclusion Criteria

I currently have or might have an infection.

You have used illegal drugs through a needle in the past year.

My BMI is over 40.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with the GORE® VIAFORT Vascular Stent and evaluated through hospital discharge

Up to 30 days

Hospital stay until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-treatment

Treatment Details

Interventions

• GORE® VIAFORT Vascular Stent

Trial Overview The trial is testing the GORE® VIAFORT Vascular Stent's performance and safety for treating adults with blocked veins in their lower body. It's a forward-looking study across multiple centers where all participants receive the stent without being compared to another group.

Participant Groups

Group I: GORE® VIAFORT Vascular Stent Experimental Treatment 1 Intervention

GORE® VIAFORT Vascular Stent

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

The Gore Viabahn VBX balloon-expandable endoprosthesis is FDA-approved for treating iliac artery stenosis, including complex lesions at the aortic bifurcation.

This case series presents the first application of the VBX covered stent in patients with congenital heart disease, showcasing its flexibility and potential advantages in this unique patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Gore Viabahn VBX balloon-expandable endoprosthesis in the congenital heart disease population. Cole, JM., Salavitabar, A., Armstrong, AK., et al.[2020]

References

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

The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction. [2018]

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

Stent placement for treatment of central and peripheral venous obstruction: a long-term multi-institutional experience. [2012]

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

Comparison between a dedicated venous stent and standard composite Wallstent-Z stent approach to iliofemoral venous stenting: Intermediate-term outcomes. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Device profile of the Vici venous stent for chronic iliofemoral venous obstruction recanalization: overview of its safety and efficacy. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Percutaneous transluminal treatment of stenoses and obstructions in the venous system using vascular endoprostheses (stents)]. [2006]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A Comparison of Patient and Device Issues Reported for Recalled Venous Stent Systems. [2022]

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

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries. [2022]

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

Stent graft treatment for infra-inguinal arterial disease for either instent-restenosis and denovo lesions associated with very high rates of failure. [2019]

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

Use of the Gore Viabahn VBX balloon-expandable endoprosthesis in the congenital heart disease population. [2020]

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

In vivo evaluation of safety and performance of a nitinol venous stent in an ovine iliac venous model. [2018]

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

Venous Stents: Current Status and Future Directions. [2018]