Venous Stent for Chronic Venous Insufficiency

(VIVID Trial)

No longer recruiting at 34 trial locations

Overseen By Steven Abramowitz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vesper Medical, Inc.

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pulmonary embolism, Coagulopathy, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of the Duo Venous Stent System for people with chronic venous insufficiency, a condition where obstructed blood flow through the veins causes leg pain and swelling. The trial targets individuals with a significant blockage in a leg vein requiring stent treatment. Ideal candidates experience symptoms like leg pain or swelling due to a vein blockage in one leg. Participants must be able to walk, even with assistance from a device like a cane. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance treatment options for chronic venous insufficiency.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Vesper DUO Venous Stent System is safe for treating chronic venous insufficiency?

Research has shown that the Duo Venous Stent System is generally safe for people. One study found that 98.7% of patients did not experience major safety issues with the stent, surpassing the target goal of 89.0%. This indicates strong safety performance. Other research has found that up to 12 months after treatment, the stent remained safe and effective for treating certain vein blockages. Additionally, tests up to 180 days revealed no major safety concerns, indicating that the stent is usually well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for chronic venous insufficiency that often involve compression therapy or surgical vein stripping, the Duo Venous Stent System offers a minimally invasive solution. This stent system is designed to provide structural support to veins, potentially improving blood flow more effectively and with less recovery time. Researchers are excited about its ability to address vein blockages directly, which could offer faster relief of symptoms compared to traditional methods.

What evidence suggests that the Duo Venous Stent System is effective for chronic venous insufficiency?

Research has shown that the Duo Venous Stent System, which participants in this trial will receive, effectively treats chronic venous insufficiency, a condition where blood doesn't flow properly through the veins. In the VIVID trial, patients reported improvements based on several measures, such as the Venous Clinical Severity Score and quality of life assessments. These improvements persisted over a year, indicating that the stent helps ease symptoms and enhance daily life. Additionally, using a balloon to open the vein and placing a stent has proven effective for people with serious vein problems, like blockages. Trials have found the system safe for humans, with no major safety issues reported. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

Adults over 18 with chronic venous insufficiency, May-Thurner Syndrome, or deep vein thrombosis who need a stent and can follow post-treatment care. Must not be pregnant/breastfeeding, have a BMI under 40, no recent COVID-19 infection or symptoms, and no history of certain blood disorders or allergies to the stent materials.

Inclusion Criteria

My veins near the target area are healthy enough for treatment.

Your body mass index (BMI) is less than 40.

I had symptoms of a deep vein clot before getting a DUO Stent.

Exclusion Criteria

Your iliofemoral veins are not the right size for the available DUO Stent implants.

You have had a condition called Heparin Induced Thrombocytopenia in the past.

My blood does not clot properly, and treatment has not worked to fix it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DUO Venous Stent System implantation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Duo Venous Stent System

Trial Overview The DUO Venous Stent System is being tested for safety and effectiveness in improving blood flow in patients with iliofemoral venous outflow obstructions. The trial compares results from this single-arm study to existing scientific data on similar treatments.

How Is the Trial Designed?

Group I: Duo Venous Stent System Implantation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vesper Medical, Inc.

Lead Sponsor

Trials

1

Recruited

160+

Citations

1. jvsvenous.org jvsvenous.org/article/S2213-333X(24)00415-3/fulltext

The VIVID trial 12-month outcomes of the venous stent for ... Patient-reported outcomes showed improvements in Venous Clinical Severity Score, Villalta, EQ-5D-3L, and VEINES-QoL/Sym scores from baseline ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39477150/

The VIVID trial 12-month outcomes of the venous stent for ... Patient-reported outcomes showed improvements in Venous Clinical Severity Score, Villalta, EQ-5D-3L, and VEINES-QoL/Sym scores from baseline ...

3. philips.com philips.com/a-w/about/news/archive/standard/news/press/2024/philips-launches-duo-venous-stent-system-for-treatment-of-symptomatic-venous-outflow-obstruction.html

Philips launches Duo Venous Stent System for treatment ... “The VIVID study's 12-month results demonstrate the safety and efficacy of the Duo Venous Stent System in the treatment of chronic venous ...

4. jvascsurg.org jvascsurg.org/article/S0741-5214(24)00583-4/fulltext

Venous Stent for the Iliofemoral Vein Investigational ... Balloon angioplasty and stenting have been shown to be effective in patients with advanced chronic venous insufficiency and venous outflow obstruction.

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230021B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Overall, the histopathological results up to 180-days using the Duo Venous Stent System did not raise any significant safety issues for clinical use in humans.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X24004153

The VIVID trial 12-month outcomes of the venous stent for ... Conclusions. Through 12 months, the Duo Venous Stent System is safe and effective for the treatment of nonmalignant iliofemoral venous obstructive disease.