Clinical trial NCT04580160: Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
Official title: Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: May-Thurner Syndrome
Deep Vein Thrombosis
Chronic Venous Insufficiency
Lead sponsor: Vesper Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 outflow obstructions.


Eligibility criteria: 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. Clinical-Etiology-Anatomy-Pathophysiology (CEAP) score ≥3
   2. Venous Clinical Severity Score (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

Primary outcomes:
measure: Safety - Number of Participants Free From Major Adverse Events (MAEs) at 30 Days
timeFrame: 30 days
measure: Efficacy - Number of Participants With Primary Patency of Stented Segment at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: VCSS Pain Score and Changes in VCSS From Baseline in ITT Patients
timeFrame: 12 months
measure: Number of ITT Subjects With Primary Assisted Patency at 12 Months
timeFrame: 12 months
measure: Number of ITT Subjects With Secondary Patency at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Darien
country: United States
facility: The Vascular Experts
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Miami Beach
country: United States
facility: Palm Vascular Centers
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center of Florida
state: Florida
city: Winter Park
country: United States
facility: University Clinical Research-Deland LLC
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Opelousas
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Dearborn
country: United States
facility: Michigan Outpatient Vascular Institute
state: Michigan
city: Englewood
country: United States
facility: Edgewood Hospital and Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Columbus
country: United States
facility: The Ohio Health Research Institute
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Houston
country: United States
facility: Houston Healthcare Medical Center
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Hurricane Cardiology Research
state: Texas
city: Norfolk
country: United States
facility: Sentara Clinical Research
state: Virginia
city: Bellevue
country: United States
facility: Lake Washington Vascular, PPLC
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Vascular & Interventional Radiology, Froedtert Hospital Radiology, Rm 2803
state: Wisconsin
city: Opole
country: Poland
facility: University Hospital in Opole
city: Poznań
country: Poland
facility: Medical University of Karol Marcinkowski
Study officials:
References: