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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04580160
Other study ID # V-CA-0001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date December 2024

Study information

Verified date November 2023
Source Vesper Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 outflow obstructions.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 162
Est. completion date December 2024
Est. primary completion date December 3, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Duo Venous Stent System
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.

Locations

Country Name City State
Poland University Hospital in Opole Opole
Poland Medical University of Karol Marcinkowski Poznan
United States Piedmont Atlanta Hospital Atlanta Georgia
United States Lake Washington Vascular, PPLC Bellevue Washington
United States Atrium Health Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States The Ohio Health Research Institute Columbus Ohio
United States The Vascular Experts Darien Connecticut
United States Midwest Cardiovascular Research Foundation Davenport Iowa
United States Michigan Outpatient Vascular Institute Dearborn Michigan
United States Edgewood Hospital and Medical Center Englewood New Jersey
United States Hartford Hospital Hartford Connecticut
United States Houston Healthcare Medical Center Houston Texas
United States North Dallas Research Associates McKinney Texas
United States Mount Sinai Medical Center of Florida Miami Florida
United States Palm Vascular Centers Miami Beach Florida
United States Medical College of Wisconsin, Vascular & Interventional Radiology, Froedtert Hospital Radiology, Rm 2803 Milwaukee Wisconsin
United States Hurricane Cardiology Research New Braunfels Texas
United States Columbia University Irving Medical Center New York New York
United States Icahn School of Medicine at Mount Sinai New York New York
United States Sentara Clinical Research Norfolk Virginia
United States Cardiovascular Institute of the South Opelousas Louisiana
United States St. Joseph Hospital Orange California
United States Stanford University Palo Alto California
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States The Miriam Hospital Providence Rhode Island
United States Stony Brook Medicine Stony Brook New York
United States Holy Name Medical Center Teaneck New Jersey
United States MedStar Washington Hospital Center Washington District of Columbia
United States University Clinical Research-Deland LLC Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Vesper Medical, Inc.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety - Freedom 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
30 days
Primary Efficacy - 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
12 months
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