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Stent
Venous Stent for Chronic Venous Insufficiency (VIVID Trial)
N/A
Waitlist Available
Research Sponsored by Vesper Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate inflow to the target lesion(s) involving at least a patent femoral or deep femoral vein and a landing zone in the CFV free from significant disease requiring treatment
In DVT subjects, successful treatment of acute thrombus must have occurred prior to receiving any DUO Stents for an underlying obstructive lesion. Successful treatment of acute thrombus is defined as reestablishment of antegrade flow with ≤30% residual thrombus (confirmed by venogram or IVUS) and freedom from bleeding and symptomatic pulmonary embolism (confirmed by imaging). After successful treatment of thrombus is confirmed, eligible obstructive lesion(s) can be treated with a DUO Stent during the same procedure
Must not have
Coagulopathy causing INR >2 which is not amenable to medical treatment
Known hypersensitivity or contraindication to antiplatelet therapy or anticoagulation, nickel, or titanium
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
VIVID Trial Summary
This trial will compare the Vesper DUO Venous Stent System to a pre-defined performance goal.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects may include pain at the insertion site, bleeding complications, allergic reactions to the stent material (nickel/titanium), clotting issues around the stent area leading to further obstruction or embolism.
VIVID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My veins near the target area are healthy enough for treatment.
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My blood clot was successfully treated, allowing for DUO Stent placement.
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I haven't had a fever or felt feverish in the last 14 days.
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I have a blockage in one of my leg's main veins.
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I haven't tested positive for COVID-19 or had symptoms in the last 60 days.
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I am an adult over 18 and not pregnant or breastfeeding if female.
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I can attend all required follow-up appointments.
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My blockage can be treated with a stent.
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I need a procedure to open a blocked vein in my leg.
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My pain level is moderate or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood does not clot properly, and treatment has not worked to fix it.
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I am allergic to antiplatelet drugs, anticoagulants, nickel, or titanium.
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I have symptoms in my limb due to poor blood flow.
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I don't currently have a significant lung clot, confirmed by a recent chest CT.
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I am planning to have additional vein-related procedures along with my main treatment.
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I am on dialysis or my kidney function is very low.
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My veins leading to my heart are blocked.
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I have a known aggressive clotting disorder.
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My treatment targets lesions extending into the IVC.
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I have a bleeding disorder that cannot be corrected.
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I have a blood clot in a limb different from the one being studied.
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I have had a vein stent placed in my leg or near my heart.
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My leg's main artery lacks a safe area for medical procedures.
VIVID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy - Primary patency of stented segment at 12 months
Safety - Freedom from major adverse events (MAEs) at 30 days
VIVID Trial Design
1Treatment groups
Experimental Treatment
Group I: Duo Venous Stent System ImplantationExperimental Treatment1 Intervention
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Who is running the clinical trial?
Vesper Medical, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your iliofemoral veins are not the right size for the available DUO Stent implants.My veins near the target area are healthy enough for treatment.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.I have a blockage in the veins on the opposite side of my body and will be treated within 390 days after my first procedure.I am allergic to antiplatelet drugs, anticoagulants, nickel, or titanium.I have no surgeries planned for conditions unrelated to my target limb 30 days before or after the main procedure.You have other health problems that the doctor thinks would make it hard for you to get this treatment or take part in the study check-ups.Your body mass index (BMI) is less than 40.Your hemoglobin level is lower than 9 grams per deciliter and has not been treated.I have symptoms in my limb due to poor blood flow.I had symptoms of a deep vein clot before getting a DUO Stent.I don't currently have a significant lung clot, confirmed by a recent chest CT.The blood vessel is big enough to fit the stent properly, as checked by IVUS.Medical devices can be used on my condition.I am planning to have additional vein-related procedures along with my main treatment.I am willing and able to follow compression therapy if my doctor recommends it.My blood clot was successfully treated, allowing for DUO Stent placement.I am not pregnant and will use birth control during the trial.I am on dialysis or my kidney function is very low.My veins leading to my heart are blocked.You have a CEAP score of 3 or higher.I haven't had a fever or felt feverish in the last 14 days.I tested negative for COVID-19 recently or have been vaccinated.I had surgery or a procedure on the vessel being studied, but if it was for DVT treatment, it was over 90 days ago.The blood vessels need to be big enough to accommodate a certain size tube used during the procedure.I have a blockage in one of my leg's main veins.I have not had or planned any major procedures on the limb being treated, except for specific treatments for blood clots, within 30 days before or after the main treatment.I have a known aggressive clotting disorder.I haven't tested positive for COVID-19 or had symptoms in the last 60 days.You are allergic to contrast agent and pre-medication cannot help manage the allergy.My treatment targets lesions extending into the IVC.I have a bleeding disorder that cannot be corrected.I am an adult over 18 and not pregnant or breastfeeding if female.I can attend all required follow-up appointments.I can walk, even if I need a cane or walker.I have a blood clot in a limb different from the one being studied.I have had a vein stent placed in my leg or near my heart.My leg's main artery lacks a safe area for medical procedures.My blockage can be treated with a stent.You are expected to live for at least 1 more year.I need a procedure to open a blocked vein in my leg.My pain level is moderate or higher.Your platelet or white blood cell counts are too low or too high.
Research Study Groups:
This trial has the following groups:- Group 1: Duo Venous Stent System Implantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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