Venous Stent for Chronic Venous Insufficiency
(VIVID Trial)
What You Need to Know Before You Apply
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.
Is the venous stent generally safe for humans?
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.26789
What data supports the effectiveness of the treatment Duo Venous Stent System for chronic venous insufficiency?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the DUO Venous Stent System implantation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Duo Venous Stent System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vesper Medical, Inc.
Lead Sponsor