Vascular Stent for Deep Vein Thrombosis

Recruiting at 28 trial locations

Overseen By Eric Hohenwalter, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Must not be taking: Antiplatelets, Thrombolytics, Anticoagulants

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

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vascular stent, the GORE® VIAFORT, to treat blockages in large veins in the pelvis and thigh area. The main goal is to determine the stent's safety and effectiveness for people with symptoms from these blockages, such as swelling or discomfort. Participants should have a diagnosed blockage in these specific veins that is not related to cancer and should be experiencing noticeable symptoms. The study seeks individuals who can walk with or without a cane and have been dealing with this issue for some time. As an unphased trial, it offers participants the chance to contribute to pioneering research that could improve treatment options for vein blockages.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to take any required medication or compression regimen as part of the study.

What prior data suggests that this vascular stent is safe for treating deep vein thrombosis?

Research has shown that the GORE® VIAFORT Vascular Stent has been tested for safety and effectiveness. Studies have found that patients generally tolerate this stent well. Serious side effects have been rare, with most patients experiencing only mild to moderate issues, if any, which are manageable and temporary.

The stent treats blockages in veins, which can cause pain and swelling. The studies evaluated its safety and effectiveness in improving blood flow. Although researchers continue to study this specific stent, stents are a well-known treatment for similar conditions, providing some confidence about its safety.

For those considering joining a trial for the GORE® VIAFORT Vascular Stent, this information can help in understanding the potential risks and benefits. Always consult a doctor for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GORE® VIAFORT Vascular Stent is unique because it offers a new approach to treating deep vein thrombosis (DVT) by directly addressing vein blockage. Unlike traditional treatments like anticoagulants that primarily prevent clotting, this stent physically opens the blocked veins, which could improve blood flow more effectively and possibly reduce symptoms faster. Researchers are excited because this method may provide a more targeted and immediate solution to DVT, potentially reducing the risk of long-term complications associated with the condition.

What evidence suggests that the GORE® VIAFORT Vascular Stent is effective for iliofemoral venous obstruction?

Research shows that the GORE® VIAFORT Vascular Stent addresses blockages in certain leg veins, which can often lead to deep vein thrombosis (DVT). Studies have found that this stent improves blood flow by keeping veins open. In previous patients, the stent proved safe and effective for similar vein blockages. Although specific data on its use for DVT is limited, its success in treating related vein issues suggests potential effectiveness. The stent aims to reduce symptoms by enhancing blood flow in the affected veins. ^{1 2 3 4 6}

Who Is on the Research Team?

Kathleen Gibson, MD

Principal Investigator

Lake Washington Vascular Surgeons

Kush Desai, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults with symptomatic vein blockages in the leg who haven't had previous stenting or grafts, don't have significant artery disease, recent major amputations, or certain blood conditions. They must be able to receive a GORE® VIAFORT Vascular Stent and follow treatment plans including medications.

Inclusion Criteria

My veins in the leg area are good enough for treatment, as decided by my doctor.

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

Patient is able to provide informed consent

Exclusion Criteria

I have a genetic blood clotting disorder.

I have a clotting disorder and cannot or will not take blood thinners long-term.

I have had symptoms of a deep vein thrombosis between 14 and 90 days ago.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• GORE® VIAFORT Vascular Stent

Trial Overview The study tests the GORE® VIAFORT Vascular Stent's performance and safety in treating venous obstructions in the leg. It's a single-arm study where all participants receive the stent to see how well it works and what risks are involved.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05409976

The GORE® VIAFORT Vascular Stent IVC Study This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949912725001126

Study design of the GORE® VIAFORT Vascular Stent trials ... This manuscript outlines two prospective studies evaluating the safety and efficacy of the investigational GORE® VIABAHN® Venous Stent, a self- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05489588

The GORE® VIAFORT Vascular Stent Iliofemoral Study This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIAFORT ...

4. withpower.com withpower.com/trial/phase-ulcer-1-2023-fd1d4

Vascular Stent for Deep Vein Thrombosis What data supports the effectiveness of the GORE® VIAFORT Vascular Stent treatment for deep vein thrombosis? While there is no direct data on the GORE® VIAFORT ...

5. researchgate.net researchgate.net/publication/395828694_Study_design_of_the_GORER_VIAFORT_Vascular_Stent_trials_for_the_treatment_of_symptomatic_inferior_vena_cava_obstruction_with_or_without_iliofemoral_obstruction_and_unilateral_iliofemoral_obstruction

Study design of the GORE® VIAFORT Vascular Stent trials ... The blood pool phase of the study revealed bilaterally distorted inferior epigastric veins mimicking normal venous flow pattern. The authors ...

6. med.stanford.edu med.stanford.edu/ir/clinical-trials/gore-viafort-ivc-study.html

The GORE® VIAFORT Vascular Stent IVC Study This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular ...