165 Participants Needed

Vascular Stent for Deep Vein Thrombosis

Recruiting at 24 trial locations
LR
CC
SA
EH
Overseen ByEric Hohenwalter, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic iliofemoral venous obstruction.

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.

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

The GORE® Viabahn® Endoprosthesis, a similar stent, has been studied for safety in treating peripheral arterial disease, showing low rates of serious adverse events within 30 days. In one study, only 2.8% of patients experienced a procedure-related adverse event, indicating it is generally safe when used as intended.12345

How is the GORE® VIAFORT Vascular Stent treatment for deep vein thrombosis different from other treatments?

The GORE® VIAFORT Vascular Stent is unique because it likely incorporates a dual component design similar to the GORE® TIGRIS® Vascular Stent, which uses a nitinol wire frame combined with a fluoropolymer structure, offering flexibility and durability that may enhance blood flow and reduce complications compared to traditional stents.13567

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 Vascular Stent for deep vein thrombosis, similar stents by Gore, like the Viabahn Endoprosthesis, have shown promising results in maintaining open blood vessels in other conditions, such as peripheral artery disease, which suggests potential effectiveness.258910

Who Is on the Research Team?

Kush R. Desai, MD | Northwestern Medicine

Kush Desai, MD

Principal Investigator

Northwestern University

Dr. Kathleen Gibson, MD - Bellevue, WA ...

Kathleen Gibson, MD

Principal Investigator

Lake Washington Vascular Surgeons

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
See 12 more

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.
See 16 more

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?
1Treatment groups
Experimental Treatment
Group I: GORE® VIAFORT Vascular StentExperimental Treatment1 Intervention

Find a Clinic Near You

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

French multicenter experience with the GORE TIGRIS Vascular Stent in superficial femoral and popliteal arteries. [2018]
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]
Use of an ePTFE-covered nitinol self-expanding stent graft for the treatment off pre-closure device failure during transcatheter aortic valve replacement. [2017]
Value of covered stents to improve patency of long-segment SFA revascularization. [2016]
Treatment of focal distal abdominal aortic stenosis with the GORE VIABAHN VBX balloon expandable covered stent. [2020]
Stent graft treatment for infra-inguinal arterial disease for either instent-restenosis and denovo lesions associated with very high rates of failure. [2019]
The use of the GORE® TIGRIS® Vascular Stent with dual component design in the superficial femoral and popliteal arteries at 6 months. [2016]
Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial. [2014]
Twelve-month experience with the GORE® TIGRIS® Vascular Stent in the superficial femoral and popliteal arteries. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Use of the Gore Tigris Vascular Stent in Advanced Femoropopliteal Peripheral Arterial Disease. [2018]
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