Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System (VIVID)

November 15, 2023 updated by: Vesper Medical, Inc.
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 Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Opole, Poland, 45-401
        • University Hospital in Opole
      • Poznań, Poland, 61-484
        • Medical University of Karol Marcinkowski
    • California
      • Orange, California, United States, 92868
        • St. Joseph Hospital
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • The Vascular Experts
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Miami, Florida, United States, 33140
        • Mount Sinai Medical Center of Florida
      • Miami Beach, Florida, United States, 33140
        • Palm Vascular Centers
      • Winter Park, Florida, United States, 32792
        • University Clinical Research-Deland LLC
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Iowa
      • Davenport, Iowa, United States, 52801
        • Midwest Cardiovascular Research Foundation
    • Louisiana
      • Opelousas, Louisiana, United States, 70570
        • Cardiovascular Institute of the South
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Michigan Outpatient Vascular Institute
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Edgewood Hospital and Medical Center
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • Stony Brook, New York, United States, 11790
        • Stony Brook Medicine
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health
    • Ohio
      • Columbus, Ohio, United States, 43214
        • The Ohio Health Research Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
    • Texas
      • Houston, Texas, United States, 77090
        • Houston Healthcare Medical Center
      • McKinney, Texas, United States, 75069
        • North Dallas Research Associates
      • New Braunfels, Texas, United States, 78130
        • Hurricane Cardiology Research
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Clinical Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Lake Washington Vascular, PPLC
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin, Vascular & Interventional Radiology, Froedtert Hospital Radiology, Rm 2803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males or non-pregnant, non-breastfeeding females ≥18 years of age at the time of consent
  2. Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
  3. 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
  4. Willing and capable of complying with all required follow-up visits
  5. Estimated life expectancy ≥1 year
  6. Subject is ambulatory (use of assistive walking device such as a cane or walker is acceptable)
  7. Body mass index (BMI) <40
  8. 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:

    1. CEAP score ≥3
    2. VCSS pain score ≥2
    3. Suspected deep vein thrombosis (DVT) with symptoms occurring prior to receiving a DUO Stent
  9. Subject is willing and able to comply with PI recommendation for compression therapy, if required
  10. 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
  11. Obstructive lesion(s) able to be treated with continuous stent coverage
  12. 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
  13. Reference vessel diameter is of adequate size to accommodate the appropriate size stent as measured by IVUS
  14. All vessels from insertion site through target vessel can accommodate a 9F or 10F sheath, depending on the stent size used
  15. Ability to cross interventional devices through target lesion(s)
  16. 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.
  17. 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.
  18. 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
  19. No prior history, within 60 days of the index procedure, of a SARS-CoV-2 positive test, or COVID-19 symptoms

Exclusion Criteria:

  1. Target limb symptoms caused by peripheral arterial disease
  2. 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.
  3. Presence of IVC obstruction or target venous obstruction that extends into the IVC
  4. Presence of acute DVT located outside target limb
  5. Contralateral venous occlusive disease of the CFV, EIV, and/or CIV, with planned treatment ≤390 days after the index procedure
  6. Uncontrolled or active coagulopathy or known, uncorrectable bleeding diathesis
  7. Coagulopathy causing INR >2 which is not amenable to medical treatment
  8. 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
  9. Uncorrected hemoglobin of ≤9 g/dL
  10. Subject is on dialysis or has an estimated glomerular filtration rate (eGFR) <30 mL/min. In subjects with diabetes mellitus, eGFR <45 mL/min.
  11. History of Heparin Induced Thrombocytopenia
  12. 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
  13. Known hypersensitivity or contraindication to antiplatelet therapy or anticoagulation, nickel, or titanium
  14. Contrast agent allergy that cannot be managed adequately with pre-medication
  15. 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
  16. 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
  17. 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
  18. 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
  19. Previous venous stenting of the target limb, the IVC, or contralateral limb if stents extend into the IVC
  20. Iliofemoral venous segment unsuitable for treatment with available sizes of DUO Stent implants
  21. Lesions with intended treatment lengths extending into the IVC
  22. No safe landing zone at or above the profunda femoral confluence
  23. Participating in another investigational study in which the subject has not completed the primary endpoint(s)
  24. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duo Venous Stent System Implantation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Freedom 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
30 days
Efficacy - 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2020

Primary Completion (Actual)

December 3, 2022

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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