Vascular Stent for Venous Obstruction

Not currently recruiting at 22 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the GORE® VIAFORT Vascular Stent, designed to assist individuals with blockages in the inferior vena cava, a major vein that can cause significant health issues if obstructed. Researchers seek to determine if this stent safely improves blood flow and reduces symptoms. Potential participants have experienced symptoms such as pain and swelling due to vein blockages and can walk, even with the aid of a cane or walker.

As an unphased trial, this study provides patients the opportunity to contribute to medical advancements and potentially experience symptom relief.

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 prior data suggests that the GORE® VIAFORT Vascular Stent is safe for treating venous obstruction?

Research shows that the GORE® VIAFORT Vascular Stent is undergoing tests to treat blockages in veins. This treatment targets blockages in the inferior vena cava (a large vein that carries blood to the heart) and possibly in the iliofemoral veins (veins in the pelvis and thigh).

Although limited safety data exists for the GORE® VIAFORT Vascular Stent, a similar product, the GORE® Viabahn stent, has been used safely for conditions like peripheral arterial disease. This suggests that the VIAFORT stent might also be safe. However, further research is necessary to confirm its safety for this specific use.

Overall, while the VIAFORT stent appears promising, participants should be aware that long-term safety information is still being collected. Discussing any concerns with healthcare providers before joining the trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GORE® VIAFORT Vascular Stent is unique because it specifically targets venous obstructions with advanced design features that enhance blood flow. Unlike traditional metal stents, this stent is engineered to conform better to the vessel's natural shape, reducing the risk of movement or misplacement. Researchers are excited about this treatment because it promises improved durability and flexibility, potentially offering a more reliable and long-lasting solution for patients with venous blockages.

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

Research has shown that the GORE® VIAFORT Vascular Stent, which participants in this trial will receive, successfully treats blocked veins. Studies have found this stent to be both effective and safe for patients with blockages in major veins, such as the inferior vena cava and iliofemoral veins. These studies demonstrated good results, indicating that the stent can improve blood flow and reduce symptoms caused by blocked veins. Designed to be flexible and strong, the stent helps keep veins open and functioning well. Overall, the evidence supports its potential effectiveness for people with symptoms from blocked veins. ^{1 2 5 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 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 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.

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

Published Research Related to This Trial

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]

Citations

1. 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 ...

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/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 ...

4. withpower.com withpower.com/trial/phase-post-thrombotic-syndrome-6-2022-e75fc

Vascular Stent for Venous Obstruction · Info for Participants 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 ...

5. med.stanford.edu med.stanford.edu/ir/clinical-trials/gore-viafort-iliofemoral-study.html

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 ...

6. goremedical.com goremedical.com/conditions-procedures/venous-disease

Understanding Venous Disease For treatment of symptomatic iliofemoral venous obstruction, a clinical study will evaluate the performance, safety and efficacy of using the investigational ...

7. cms.gov cms.gov/medicare/coverage/ide/approved-ide-studies/g220169-nct05489588

G220169-NCT05489588 Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction. Sponsor Name. W.L.Gore & Associates. NCT Number.