BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease

NCT02655887 | Completed Results DMC FDA Device

• 1 other identifier: BPV-14-007
• Study Type: interventional
• Target: 170
• Locations: 7 countries
• Sites: 21

Brief Summary

The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease.

Conditions

May-Thurner Syndrome; Peripheral Vascular Disease; Venous Disease; Iliofemoral Occlusive Disease

Keywords

Vernacular; Iliofemoral Occlusive Disease

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure

  Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis \> 50% as measured by Duplex Ultrasound (DUS). Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.

  12 months post-index procedure

• Number of Participants With Freedom From Major Adverse Events (MAEs)

  Freedom from major adverse events (MAEs) defined as: Target Vessel Revascularization; Device and/or procedure related death; Major amputation of target limb; Pulmonary Embolism which is clinically important; Vascular injury requiring surgical/endovascular intervention; Embolization /migration of stent; Device or procedure related acute DVT involving the treated limb. Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.

  30 days post-index procedure

Secondary Outcomes (9)

• Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months

  Evaluation at 12 months post-index procedure

• Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months

  Evaluation at 12 months post-index procedure

• Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure

  Evaluation through 30 day, 6 months and 12 months post index procedure

• Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success

  At time of Index Procedure

• Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)

  Less than 30 days post index procedure

Study Arms (1)

VENOVO™ Venous Stent.

EXPERIMENTAL

Implant of the VENOVO™ Venous Stent

Device: VENOVO™ Venous Stent

Interventions

VENOVO™ Venous Stent DEVICE

VENOVO™ Venous stent placement

VENOVO™ Venous Stent.

Eligibility Criteria

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

You may qualify if:

• The subject provides written informed consent using an Informed Consent Form approved by Ethics Committee/ Institutional Review Board for the site.
• Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
• The subject is a male or non-pregnant female ≥ 18 years old with an expected lifespan sufficient to allow for completion of all study procedures.
• The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral "venous segments".
• The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral venous segments(Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) "C" ≥ 3 or VCSS pain score of ≥ 2).
• The subject is able and willing to comply with any required medication regimen.
• The reference vessel diameters are between 7mm and 19 mm.

You may not qualify if:

• Subject is unable or unwilling to provide written informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
• Subject is or plans to become pregnant during the study.
• Subject has contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof and does not meet the venous outflow obstruction requirement or has a malignant obstruction.
• The subject is asymptomatic, has a CEAP "C" \<3, or a VCSS pain score of \<2.
• The subject has a venous obstruction that extends into the inferior vena cava (IVC) or below the level of the lesser trochanter.
• The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
• The subject has a known allergy or sensitivity to Nickel or Titanium or intolerance to antiplatelet, anticoagulant or thrombolytic medications medications required per the protocol
• The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
• The subject has any planned surgical interventions within 30 days prior to, or within 30 days after the planned study procedure.
• The subject has a lesion or occlusion which cannot be traversed with a guidewire.
• The subject has had prior stenting in the target vessel.
• The subject has iliofemoral venous segments unsuitable for treatment with available sizes of study devices.
• The subject has another medical condition, which may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow completion of study procedures and follow ups.
• The subject is currently participating in an investigational drug, biologic, or another device study.
• The subject is currently on dialysis or has a serum creatinine ≥2.5mg/dl.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (21)

Vascular Breakthroughs, LLC

Darien, Connecticut, 06820, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Cox Medical Centers

Springfield, Missouri, 65807, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

North Carolina Heart and Vascular

Raleigh, North Carolina, 27607, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78746, United States

Location

Centra Health, Inc., dba Stroobants Cardiovascular Center

Lynchburg, Virginia, 24501, United States

Location

Sentara Medical Group

Virginia Beach, Virginia, 23542, United States

Location

Lake Washington Vascular, PLLC

Bellevue, Washington, 98004, United States

Location

CAMC Health Education and Research Institute

Charleston, West Virginia, 25304, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH

Perth, Western Australia, 6009, Australia

Location

Uniklinik RWTH

Aachen, 52074, Germany

Location

Klinikum Arnberg

Arnsberg, 59755, Germany

Location

Universitaets-Herrzentrum Freiburg-Bad Krozingen

Bad Krozingen, 79189, Germany

Location

University Hospital Galway

Galway, H91 YR71, Ireland

Location

MUMC Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Fundacion de investigacion HM Hospitales

Madrid, 28660, Spain

Location

Guy's & St. Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

• Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.

  PMID: 39968829 DERIVED

• Dake MD, O'Sullivan G, Shammas NW, Lichtenberg M, Mwipatayi BP, Settlage RA; VERNACULAR Trial Investigators. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1918-1929. doi: 10.1007/s00270-021-02975-2. Epub 2021 Sep 20.

  PMID: 34545448 DERIVED

MeSH Terms

Conditions

May-Thurner Syndrome; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Megan Hill
• Organization: Becton Dickinson (BPV)

Megan.Hill@bd.com

480-350-6468

Study Officials

• Michael Dake, MD

  Lead Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: January 7, 2016
• First Posted: January 14, 2016
• Study Start: June 15, 2016
• Primary Completion: June 19, 2018
• Study Completion: October 30, 2020
• Last Updated: February 4, 2021
• Results First Posted: June 12, 2019

Record last verified: 2021-01

Locations

US (12); NL (1); ES (1); GB (1); AU (2); DE (3); IE (1)