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

The BARD® VENOVO™ Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease - an Assessment for Effectiveness and Safety (VERNACULAR)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease; Venous Disease; May-Thurner Syndrome; Iliofemoral Occlusive Disease
• Intervention / Treatment: Device: VENOVO™ Venous Stent

Detailed Description

This is a prospective, multi-center, non-randomized, single-arm clinical study of the VENOVO ™ Venous Stent for the treatment of iliofemoral occlusive disease. The study will be conducted at a maximum of 35 investigational sites ("sites") in the United States, and Europe and Australia/New Zealand. Enrollment will continue until a maximum of one hundred seventy (170) subjects are treated with the VENOVO™ Venous Stent, which is an estimated three-hundred forty (340) consecutive subjects in a non-randomized fashion. It is assumed that approximately 50% of the treated subjects will be U.S. subjects. Clinical follow-up for all treated subjects will be performed at hospital discharge, 30-days, and 6-, 12-, 24-, and 36-months post-index procedure.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH
• Germany
  • Aachen, Germany, 52074
    • Uniklinik RWTH
  • Arnsberg, Germany, 59755
    • Klinikum Arnberg
  • Bad Krozingen, Germany, 79189
    • Universitaets-Herrzentrum Freiburg-Bad Krozingen
• Ireland
  • Gaillimh, Ireland, H91 YR71
    • University Hospital Galway
• Netherlands
  • Maastricht, Netherlands, 6202 AZ
    • MUMC Maastricht
• Spain
  • Madrid, Spain, 28660
    • Fundacion de investigacion HM Hospitales
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guy's & St. Thomas' Hospital
• United States
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • Vascular Breakthroughs, LLC
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health Hospital
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Cox Medical Centers
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Heart and Vascular
  • Texas
    • Austin, Texas, United States, 78746
      • Cardiothoracic and Vascular Surgeons
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Centra Health, Inc., dba Stroobants Cardiovascular Center
    • Virginia Beach, Virginia, United States, 23542
      • Sentara Medical Group
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular, PLLC
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Education and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject provides written informed consent using an Informed Consent Form approved by Ethics Committee/ Institutional Review Board for the site.
2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
3. 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.
4. The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral "venous segments".
5. 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).
6. The subject is able and willing to comply with any required medication regimen.
7. The reference vessel diameters are between 7mm and 19 mm.

Exclusion Criteria:

1. 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.
2. Subject is or plans to become pregnant during the study.
3. 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.
4. The subject is asymptomatic, has a CEAP "C" <3, or a VCSS pain score of <2.
5. The subject has a venous obstruction that extends into the inferior vena cava (IVC) or below the level of the lesser trochanter.
6. The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
7. 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
8. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
9. The subject has any planned surgical interventions within 30 days prior to, or within 30 days after the planned study procedure.
10. The subject has a lesion or occlusion which cannot be traversed with a guidewire.
11. The subject has had prior stenting in the target vessel.
12. The subject has iliofemoral venous segments unsuitable for treatment with available sizes of study devices.
13. 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.
14. The subject is currently participating in an investigational drug, biologic, or another device study.
15. The subject is currently on dialysis or has a serum creatinine ≥2.5mg/dl.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VENOVO™ Venous Stent.; Implant of the VENOVO™ Venous Stent	Device: VENOVO™ Venous Stent; VENOVO™ Venous stent placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months	The Venous Clinical Severity Score (VCSS) system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration. and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 means absent, 1 means mild, 2 means moderate and 3 means severe. Total VCSS is the sum of all VCSS assessment scores from categories for a given time point. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for Intent-to-Treat (ITT) subjects. Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline.	Evaluation at 12 months post-index procedure
Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months	The Quality of Life (QoL) assessment of Chronic Venous Insufficiency Questionnaire (CIVIC-20) is a 20-item questionnaire which provides a global index and an outline of 4 QoL dimensions - pain (4 items), physical (4 items), psychological (9 items) and social (4 items). Items are scored on a scale from 1 to 5. A low score corresponds to greater patient comfort. Total CIVIQ-20 score is the sum of all 20-item scores The score of each dimension was obtained by adding up the scores of each constituent item within that dimension. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for evaluable ITT subjects. Lower values represent a better outcome, that is, a better QoL than that experienced at baseline.	Evaluation at 12 months post-index procedure
Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure	Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification is a system that describes a doctor's physical exam findings for vein problem(s), the cause of the problem(s), the location in the leg, and the mechanism responsible for the manifestation of the vein problem. For Clinical classification, the clinical components indicates disease severity, ranging from none (0 points) to active ulcers (6 points).For each category of Etiology, Anatomy, and Pathophysiology classifications, at each time point, frequency of each category is reported. Subsequent clinical study reports will present CEAP at 24 and 36-months follow-up. Changes from baseline measures to given time points are presented. Lower mean scores represent an improvement from baseline measure.	Evaluation through 30 day, 6 months and 12 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success	Acute technical success is defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator.	At time of Index Procedure
Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)	Technical success is defined as no major adverse events experienced between index procedure and discharge	Less than 30 days post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects)	Lesion Success is defined as the attainment of less or equal to 50% residual stenosis at the conclusion of the index procedure.	At the conclusion of index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects)	Freedom from Target Lesion Revascularization (TLR) through 30 days is specific to the first revascularization procedure of the target lesion.	Evaluation throrugh 30 day, 6 months and 12 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects)	Freedom from Target Vessel Revascularization (TVR) is defined as the first revascularization procedure of the target vessel, as determined by an Independent Core Lab. Freedom from Target Lesion Revascularization (TLR) and Freedom from TVR results are the same through the 12 month analysis as all TLRs were also TVRs in this case.	Evaluation through 30 days, 6 months and 12 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up	Stents were evaluated at the 12 month follow-up for fracture analysis. Evaluable ITT subjects are included in this analysis.	Evaluation at 12 months post-index procedure

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Michael Dake, MD, Lead Principal Investigator

Publications and helpful links

General Publications

• 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. Erratum in: Cardiovasc Intervent Radiol. 2021 Oct 19;:.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2016
• Primary Completion (Actual): June 19, 2018
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: January 7, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Vernacular; Iliofemoral Occlusive Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Congenital Abnormalities; Atherosclerosis; Cardiovascular Abnormalities; Vascular Malformations; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; May-Thurner Syndrome
• Other Study ID Numbers: BPV-14-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes