May-Thurner SyndromeVIVIDNCT04580160
Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
A study testing Duo Venous Stent System in people with May-Thurner Syndrome and Deep Vein Thrombosis, run by Vesper Medical, Inc. at 30 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- May-Thurner Syndrome, Deep Vein Thrombosis, Chronic Venous Insufficiency
- What is being tested?
- Duo Venous Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 30 Nov 2020to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or non-pregnant, non-breastfeeding females ≥18 years of age at the time of consent
- Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
- Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to treatment and must use some form of contraception (abstinence is acceptable) throughout the time of clinical trial exit
- Willing and capable of complying with all required follow-up visits
- Estimated life expectancy ≥1 year
- Subject is ambulatory (use of assistive walking device such as a cane or walker is acceptable)
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- Body mass index (BMI) <40
- Clinically significant symptomatic venous outflow obstruction in one iliofemoral venous segment (one limb) per subject, is indicated for venoplasty and stenting, and meets at least one of the following clinical indicators:
- Clinical-Etiology-Anatomy-Pathophysiology (CEAP) score ≥3
- Venous Clinical Severity Score (VCSS) pain score ≥2
- Suspected deep vein thrombosis (DVT) with symptoms occurring prior to receiving a DUO Stent
- Subject is willing and able to comply with PI recommendation for compression therapy, if required
- Presence of unilateral, non-malignant venous obstruction of the common femoral vein (CFV), external iliac vein (EIV), common iliac vein (CIV), or any combination thereof, defined as a ≥50% reduction in target vessel lumen diameter and confirmed by venographic or IVUS imaging. The cranial point of the obstruction may extend to the iliac vein confluence of the inferior vena cava (IVC) and the caudal point may be 2mm above either the inflow of the deep femoral (or profunda) or the lesser trochanter, whichever is most cranial
- Obstructive lesion(s) able to be treated with continuous stent coverage
- 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
- Reference vessel diameter is of adequate size to accommodate the appropriate size stent as measured by IVUS
- All vessels from insertion site through target vessel can accommodate a 9F or 10F sheath, depending on the stent size used
- Ability to cross interventional devices through target lesion(s)
- 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.
- All subjects must undergo a SARS-CoV-2 test and have a negative test result within 8 days of the index procedure. If a SARS-CoV-2 test is unavailable due to institution policy, a test shortage, or if there is a delay in test results, the subject must complete the COVID-19 questionnaire and must have answered NO to all questions to be eligible for enrollment. A SARS-CoV-2 test will not be required for enrollment if a subject has received a complete cycle of an authorized COVID-19 vaccine or has documented evidence of a positive COVID-19 antibody test and is asymptomatic and has no long-lasting effects (per PI discretion) from a prior COVID-19 infection.
- A measured temperature less than 99.5°F (37.5°C) on the day of the index procedure and no history of fever or feeling feverish within 14 days of the index procedure
- No prior history, within 60 days of the index procedure, of a SARS-CoV-2 positive test, or COVID-19 symptoms
Who cannot join
- Target limb symptoms caused by peripheral arterial disease
- Presence of unresolved significant pulmonary embolism prior to use of the DUO Venous Stent System confirmed by chest CT. If subject has documented history of significant pulmonary embolism within the last 6 months, a chest CT is required to confirm significant pulmonary embolism is not currently present.
- Presence of IVC obstruction or target venous obstruction that extends into the IVC
- Presence of acute DVT located outside target limb
- Contralateral venous occlusive disease of the CFV, EIV, and/or CIV, with planned treatment ≤390 days after the index procedure
- Uncontrolled or active coagulopathy or known, uncorrectable bleeding diathesis
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- Coagulopathy causing INR >2 which is not amenable to medical treatment
- Platelet count <50,000 cells/mm3 or >1,000,000 cells/mm3 and/or White blood cell (WBC) <3,000 cells/mm3 or >12,500 cells/mm3
- Uncorrected hemoglobin of ≤9 g/dL
- Subject is on dialysis or has an estimated glomerular filtration rate (eGFR) <30 mL/min. In subjects with diabetes mellitus, eGFR <45 mL/min.
- History of Heparin Induced Thrombocytopenia
- Presence of known aggressive clotting disorders such as Lupus Anticoagulant Disorder, Antiphospholipid antibody syndrome, homozygous gene Factor V Leiden or Prothrombin gene abnormalities, Protein C and S deficiency or Antithrombin deficiency
- Known hypersensitivity or contraindication to antiplatelet therapy or anticoagulation, nickel, or titanium
- Contrast agent allergy that cannot be managed adequately with pre-medication
- Intended concurrent adjuvant procedure (except for venoplasty) such as creation of temporary arteriovenous fistula, femoral endovenectomy or saphenous vein ablation and/or saphenous vein stripping during the index procedure
- Subjects who have had any prior surgical or endovascular procedures to the target vessel. Note that subjects who have had successful catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 90 days prior to the index procedure may be included
- Planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in subjects at high risk for pulmonary embolism) within 30 days prior to or 30 days after the index procedure
- Planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) 30 days prior to or 30 days after the index procedure
- Previous venous stenting of the target limb, the IVC, or contralateral limb if stents extend into the IVC
- Iliofemoral venous segment unsuitable for treatment with available sizes of DUO Stent implants
- Lesions with intended treatment lengths extending into the IVC
- No safe landing zone at or above the profunda femoral confluence
- Participating in another investigational study in which the subject has not completed the primary endpoint(s)
- Has other comorbidities that, in the opinion of the Investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States28 sites
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Lake Washington Vascular, PPLC
Bellevue, Washington, 98004
Atrium Health
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
The Ohio Health Research Institute
Columbus, Ohio, 43214
The Vascular Experts
Darien, Connecticut, 06820
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52801
Michigan Outpatient Vascular Institute
Dearborn, Michigan, 48126
Edgewood Hospital and Medical Center
Englewood, New Jersey, 07631
Hartford Hospital
Hartford, Connecticut, 06106
Houston Healthcare Medical Center
Houston, Texas, 77090
North Dallas Research Associates
McKinney, Texas, 75069
Mount Sinai Medical Center of Florida
Miami, Florida, 33140
Palm Vascular Centers
Miami Beach, Florida, 33140
Medical College of Wisconsin, Vascular & Interventional Radiology, Froedtert Hospital Radiology, Rm 2803
Milwaukee, Wisconsin, 53226
Hurricane Cardiology Research
New Braunfels, Texas, 78130
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Irving Medical Center
New York, New York, 10032
Sentara Clinical Research
Norfolk, Virginia, 23507
Cardiovascular Institute of the South
Opelousas, Louisiana, 70570
St. Joseph Hospital
Orange, California, 92868
Stanford University
Palo Alto, California, 94304
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
The Miriam Hospital
Providence, Rhode Island, 02906
Stony Brook Medicine
Stony Brook, New York, 11790
Holy Name Medical Center
Teaneck, New Jersey, 07666
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
University Clinical Research-Deland LLC
Winter Park, Florida, 32792
Poland2 sites
University Hospital in Opole
Opole, 45-401
Medical University of Karol Marcinkowski
Poznan, 61-484
About this study
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.
- Being tested
- Duo Venous Stent System
- Medical subject headings
- May-Thurner Syndrome, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duo Venous Stent SystemDevice
Subjects with nonmalignant iliofemoral venous outflow obstruction presenting with nonthrombotic (NT), acute thrombotic (AT) or chronic postthrombotic (CPT) disease pathogenesis will be selected for study participation.
| Study group | Role | What they receive |
|---|---|---|
| Duo Venous Stent System Implantation | Experimental | Not described Receives: Device: Duo Venous Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Number of Participants Free From Major Adverse Events (MAEs) at 30 Days
Freedom from major adverse events (MAEs) at 30 days post index procedure, as adjudicated by the Clinical Events Committee (CEC) or Core Laboratory, including:
- Device or procedure-related death
- Device or procedure-related bleed at the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention or blood transfusion of ≥2 units
- Device or procedure-related venous injury occurring in the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention
- Major amputation of the target limb
- Clinically significant pulmonary embolism (PE), confirmed by CT angiography
- Stent embolization outside of the target vessel
- Presence of new thrombus within the stented segment requiring surgical or endovascular intervention
Measured: 30 days
Efficacy - Number of Participants With Primary Patency of Stented Segment at 12 Months
Primary patency of stented segment at 12 months defined as freedom from:
- Duplex Ultrasound (DUS) core laboratory adjudicated occlusion or stenosis >50% within the stented segment. If DUS shows >50% stenosis or occlusion, confirmation by diagnostic intravascular ultrasound (IVUS) is required.
- CEC adjudicated clinically driven target lesion reintervention (CD-TLR) defined as endovascular or surgical procedure for new, recurrent, or worsening symptoms and core lab adjudicated >50% stenosis or occlusion within the stented segment confirmed by diagnostic IVUS
Measured: 12 months
Secondary outcomes (3)
VCSS Pain Score and Changes in VCSS From Baseline in ITT Patients
The Venous Clinical Severity Score (VCSS) system is a scoring system used to categorize nine attributes of venous disease. For this study, only the Pain Score was collected. The levels of pain severity ranged from 0 (none) to 3 (severe).
Measured: 12 months
Number of ITT Subjects With Primary Assisted Patency at 12 Months
Primary assisted patency is defined as freedom from DUS core laboratory adjudicated occlusion or stenosis >50% within the stented segment following a reintervention due to a >50% but <100% stenosis. If DUS shows >50% stenosis or occlusion, confirmation by diagnostic IVUS is required.
Measured: 12 months
Number of ITT Subjects With Secondary Patency at 12 Months
Secondary patency at 12 months defined as freedom from DUS core laboratory adjudicated occlusion or stenosis >50% within the stented segment following a reintervention due to 100% occlusion. If DUS shows >50% stenosis or occlusion, confirmation by diagnostic IVUS is required.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start30 Nov 2020
- Primary completion3 Dec 2022
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for May-Thurner SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vesper Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580160
- Sponsor's protocol ID
- V-CA-0001
- Acronym
- VIVID
- Status last verified
- Jan 2025
- First submitted
- 1 Oct 2020
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
- ClinicalTrials.gov ID
- NCT04580160
- Acronym / sponsor ID
- VIVID / V-CA-0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Vesper Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 3 Dec 2022 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duo Venous Stent System Implantation | Experimental | Device: Duo Venous Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Males or non-pregnant, non-breastfeeding females ≥18 years of age at the time of consent
- Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
- Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to treatment and must use some form of contraception (abstinence is acceptable) throughout the time of clinical trial exit
- Willing and capable of complying with all required follow-up visits
- Estimated life expectancy ≥1 year
Key exclusion criteria (24 listed)
- Target limb symptoms caused by peripheral arterial disease
- Presence of unresolved significant pulmonary embolism prior to use of the DUO Venous Stent System confirmed by chest CT. If subject has documented history of significant pulmonary embolism within the last 6 months, a chest CT is required to confirm significant pulmonary embolism is not currently present.
- Presence of IVC obstruction or target venous obstruction that extends into the IVC
- Presence of acute DVT located outside target limb
- Contralateral venous occlusive disease of the CFV, EIV, and/or CIV, with planned treatment ≤390 days after the index procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duo Venous Stent SystemSubjects with nonmalignant iliofemoral venous outflow obstruction presenting with nonthrombotic (NT), acute thrombotic (AT) or chronic postthrombotic (CPT) disease pathogenesis will be selected for study participation. | Device | Duo Venous Stent System Implantation |
Primary outcome
Safety - Number of Participants Free From Major Adverse Events (MAEs) at 30 Days
Time frame: 30 days
Freedom from major adverse events (MAEs) at 30 days post index procedure, as adjudicated by the Clinical Events Committee (CEC) or Core Laboratory, including: * Device or procedure-related death * Device or procedure-related bleed at the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention or blood transfusion of ≥2 units * Device or procedure-related venous injury occurring in the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention * Major amputation of the target limb * Clinically significant pulmonary embolism (PE), confirmed by CT angiography * Stent embolization outside of the target vessel * Presence of new thrombus within the stented segment requiring surgical or endovascular intervention
Efficacy - Number of Participants With Primary Patency of Stented Segment at 12 Months
Time frame: 12 months
Primary patency of stented segment at 12 months defined as freedom from: * Duplex Ultrasound (DUS) core laboratory adjudicated occlusion or stenosis >50% within the stented segment. If DUS shows >50% stenosis or occlusion, confirmation by diagnostic intravascular ultrasound (IVUS) is required. * CEC adjudicated clinically driven target lesion reintervention (CD-TLR) defined as endovascular or surgical procedure for new, recurrent, or worsening symptoms and core lab adjudicated >50% stenosis or occlusion within the stented segment confirmed by diagnostic IVUS
3 secondary outcomes
VCSS Pain Score and Changes in VCSS From Baseline in ITT Patients
Time frame: 12 months
Number of ITT Subjects With Primary Assisted Patency at 12 Months
Time frame: 12 months
Number of ITT Subjects With Secondary Patency at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duo Venous Stent System in people with May-Thurner Syndrome and Deep Vein Thrombosis, run by Vesper Medical, Inc. at 30 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Number of Participants Free From Major Adverse Events (MAEs) at 30 Days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.