Venous Stent for Chronic Venous Insufficiency

(VIVID Trial)

Recruiting at 32 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

162 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to investigate the safety and efficacy of the Vesper DUO Venous Stent System as compared to a pre-defined performance goal (PG) established from published, peer reviewed scientific literature related to stenting of iliofemoral venous outflow obstructions.

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 data supports the effectiveness of the treatment Duo Venous Stent System for chronic venous insufficiency?

Research shows that venous stenting, like the Duo Venous Stent System, can be effective in treating chronic venous insufficiency by addressing vein obstructions and improving blood flow, as seen in studies where stents were used to treat iliac vein obstruction and deep venous reflux. ^{1 2 3 4 5}

Is the venous stent generally safe for humans?

Some venous stents have been recalled due to safety issues, but others have shown good short-term safety in studies. The most common problem reported is thrombosis (blood clots), which can affect how long the stent works well. ^{1 6 7 8 9}

How is the Duo Venous Stent System treatment different from other treatments for chronic venous insufficiency?

The Duo Venous Stent System is unique because it is specifically designed for venous conditions, unlike previous stents that were adapted from arterial use. It offers increased flexibility and radial force, making it more effective for treating venous obstructions and deep venous reflux, which are challenging to address with traditional methods. ^{1 2 4 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Intermediate to long-term results of repairing incompetent multiple deep venous valves using external valvular stenting. [2019]

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

Unexpected major role for venous stenting in deep reflux disease. [2016]

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

Does surgical correction of the superficial femoral vein valve change the course of varicose disease? [2016]

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

Pivotal Study of Endovenous Stent Placement for Symptomatic Iliofemoral Venous Obstruction. [2020]

5. Italy pubmed.ncbi.nlm.nih.gov

Endovenous laser therapy with echosclerotherapy as a hybrid method for chronic venous insufficiency: experience in 200 patients and literature review. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A Comparison of Patient and Device Issues Reported for Recalled Venous Stent Systems. [2022]

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

Evaluation of safety and performance of a new prototype self-expandable nitinol venous stent in an ovine model. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Preliminary report on a new concept stent prototype designed for venous implant. [2016]

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

Percutaneous venous valve designs for treatment of deep venous insufficiency. [2012]

10. China pubmed.ncbi.nlm.nih.gov

Encircling suture method in the treatment of femoral venous valvular incompetency. [2004]

11. England pubmed.ncbi.nlm.nih.gov

Short-Term Clinical Experience with a Dedicated Venous Nitinol Stent: Initial Results with the Sinus-Venous Stent. [2019]