Vascular Stent for Deep Vein Thrombosis

Recruiting at 24 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

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{3 6 7 9 10}

Research Team

Kush Desai, MD

Principal Investigator

Northwestern University

Kathleen Gibson, MD

Principal Investigator

Lake Washington Vascular Surgeons

Eligibility Criteria

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

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 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.

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

References

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

French multicenter experience with the GORE TIGRIS Vascular Stent in superficial femoral and popliteal arteries. [2018]

2. 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]

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

Use of an ePTFE-covered nitinol self-expanding stent graft for the treatment off pre-closure device failure during transcatheter aortic valve replacement. [2017]

4. Italy pubmed.ncbi.nlm.nih.gov

Value of covered stents to improve patency of long-segment SFA revascularization. [2016]

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

Treatment of focal distal abdominal aortic stenosis with the GORE VIABAHN VBX balloon expandable covered stent. [2020]

6. 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]

7. Italy pubmed.ncbi.nlm.nih.gov

The use of the GORE® TIGRIS® Vascular Stent with dual component design in the superficial femoral and popliteal arteries at 6 months. [2016]

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

Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial. [2014]

9. Italy pubmed.ncbi.nlm.nih.gov

Twelve-month experience with the GORE® TIGRIS® Vascular Stent in the superficial femoral and popliteal arteries. [2016]

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

Use of the Gore Tigris Vascular Stent in Advanced Femoropopliteal Peripheral Arterial Disease. [2018]