What is the mechanism of action of this treatment?

The most common treatments for venous stenosis, such as the GORE® VIAFORT Vascular Stent, involve the use of stents to provide mechanical support and maintain vessel patency. These stents are inserted into the narrowed or blocked veins to keep them open, ensuring proper blood flow. This is crucial for venous stenosis patients as it helps prevent complications like thrombosis and improves overall vascular function. By maintaining vessel patency, stents reduce symptoms and enhance the quality of life for patients suffering from venous stenosis.

What side effects are associated with this type of intervention?

Common treatments for venous stenosis, particularly those involving mechanical support such as stents, include risks of bleeding, venous reflux, and pulmonary embolization. Patients may also experience transient pain during procedures like balloon angioplasty. While these treatments are generally effective and safe, they are not without potential complications, and patient-specific factors must be considered to minimize risks.

What prior FDA approvals exist?

The FDA has approved several mechanical devices for the treatment of venous stenosis, focusing on maintaining vessel patency. These include various vascular stents such as the GORE® VIABAHN® Endoprosthesis, which is used for treating stenosis in the peripheral arteries and veins. Other similar devices include the Zilver® Vena™ Venous Stent and the VICI VENOUS STENT®, both designed to provide mechanical support and maintain patency in venous vessels. These stents are typically used to treat conditions like chronic venous obstruction and are similar in function to the GORE® VIAFORT Vascular Stent being studied.

What other types of research exist?

Promising alternatives to the GORE® VIAFORT Vascular Stent for venous stenosis patients include the Ultraflex PTFE-Plus vascular prosthesis, which has demonstrated superior handling characteristics and higher patency rates compared to traditional Gore-Tex grafts. Additionally, ongoing developments in angiogenesis inhibitors like bevacizumab, which are being evaluated for their role in vascular health, may offer novel therapeutic options. Mechanical thromboprophylaxis devices, such as intermittent pneumatic compression (IPC) devices, also provide non-stent alternatives for maintaining vessel patency.

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Vascular Stent

Vascular Stent for Venous Obstruction

N/A

Waitlist Available

Led By Kush Desai, MD

Research Sponsored by W.L.Gore & Associates

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2.

Patient is at least 18 years of age.

Must not have

Patient has a known or suspected active systemic infection at the time of the index procedure.

Patient has a BMI >40.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here for the GORE® VIAFORT Vascular Stent procedure itself; generally such interventions may include pain at insertion site, infection risk around stented area and potential clotting or migration of the stent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My vein condition is severe or causes me significant pain.

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I am 18 years old or older.

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I plan to use only the GORE® VIAFORT Vascular Stent for my treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have or might have an infection.

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My BMI is over 40.

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I have severe artery problems in my legs.

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My kidney function is very low or I am on dialysis.

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I am not pregnant, breastfeeding, planning to become pregnant, or unwilling to use birth control for the next 12 months.

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I currently have a serious lung blood clot.

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I have a bleeding disorder that cannot be corrected.

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I have had a major part of my leg amputated.

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I have a genetic blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite of efficacy and safety events

Secondary study objectives

5 Level EuroQol-5 Dimension (EQ-5D-5L)

Lesion success

Number of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GORE® VIAFORT Vascular StentExperimental Treatment1 Intervention

GORE® VIAFORT Vascular Stent

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for venous stenosis, such as the GORE® VIAFORT Vascular Stent, involve the use of stents to provide mechanical support and maintain vessel patency. These stents are inserted into the narrowed or blocked veins to keep them open, ensuring proper blood flow. This is crucial for venous stenosis patients as it helps prevent complications like thrombosis and improves overall vascular function. By maintaining vessel patency, stents reduce symptoms and enhance the quality of life for patients suffering from venous stenosis.

Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts.