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

NCT04580160 | Completed Results DMC FDA Device

• 1 other identifier: V-CA-0001
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 30

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.

Conditions

May-Thurner Syndrome; Deep Vein Thrombosis; Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 months

Secondary Outcomes (3)

• VCSS Pain Score and Changes in VCSS From Baseline in ITT Patients

  12 months

• Number of ITT Subjects With Primary Assisted Patency at 12 Months

  12 months

• Number of ITT Subjects With Secondary Patency at 12 Months

  12 months

Study Arms (1)

Duo Venous Stent System Implantation

EXPERIMENTAL

Device: Duo Venous Stent System

Interventions

Duo Venous Stent System DEVICE

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.

Duo Venous Stent System Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vesper Medical, Inc.: lead

Study Sites (30)

St. Joseph Hospital

Orange, California, 92868, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

The Vascular Experts

Darien, Connecticut, 06820, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Mount Sinai Medical Center of Florida

Miami, Florida, 33140, United States

Location

Palm Vascular Centers

Miami Beach, Florida, 33140, United States

Location

University Clinical Research-Deland LLC

Winter Park, Florida, 32792, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52801, United States

Location

Cardiovascular Institute of the South

Opelousas, Louisiana, 70570, United States

Location

Michigan Outpatient Vascular Institute

Dearborn, Michigan, 48126, United States

Location

Edgewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11790, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

The Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Houston Healthcare Medical Center

Houston, Texas, 77090, United States

Location

North Dallas Research Associates

McKinney, Texas, 75069, United States

Location

Hurricane Cardiology Research

New Braunfels, Texas, 78130, United States

Location

Sentara Clinical Research

Norfolk, Virginia, 23507, United States

Location

Lake Washington Vascular, PPLC

Bellevue, Washington, 98004, United States

Location

Medical College of Wisconsin, Vascular & Interventional Radiology, Froedtert Hospital Radiology, Rm 2803

Milwaukee, Wisconsin, 53226, United States

Location

University Hospital in Opole

Opole, 45-401, Poland

Location

Medical University of Karol Marcinkowski

Poznan, 61-484, Poland

Location

MeSH Terms

Conditions

May-Thurner Syndrome; Venous Thrombosis

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thrombosis; Embolism and Thrombosis

Results Point of Contact

• Title: Joseph C. Griffin, III
• Organization: Vesper Medical

Jgriffin@vespermedical.com

4848926340

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: November 30, 2020
• Primary Completion: December 3, 2022
• Study Completion: April 15, 2025
• Last Updated: May 15, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (28); PL (2)