Venous Stent for Chronic Venous Insufficiency

(VIVID Trial)

Recruiting at32 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vesper Medical, Inc.

No Placebo Group

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.

Research Team

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.

Treatment Details

Interventions

• Duo Venous Stent System (Stent)

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+