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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02655887
Recruitment Status : Active, not recruiting
First Posted : January 14, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

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.

Condition or disease Intervention/treatment Phase
May-Thurner Syndrome Peripheral Vascular Disease Venous Disease Iliofemoral Occlusive Disease Device: VENOVO™ Venous Stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 15, 2016
Actual Primary Completion Date : June 19, 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VENOVO™ Venous Stent.
Implant of the VENOVO™ Venous Stent
Device: VENOVO™ Venous Stent
VENOVO™ Venous stent placement




Primary Outcome Measures :
  1. Primary patency rate of the Venous Stent [ Time Frame: 12 months post index procedure ]
    Primary patency rate of the venous stent as compared to Performance Goal (PG) developed from the patency of other marketed stents at 12 months.

  2. Primary safety (number of treated subjects with freedom from major adverse events) of the Venous Stent [ Time Frame: 30 days post-index procedure ]
    Freedom from major adverse events (MAEs)


Secondary Outcome Measures :
  1. Venous Clinical Severity Score (VCSS) Pain Assessment of the BVS improves between the baseline classification and follow-up classification [ Time Frame: 12 months post-index procedure ]
    Emphasis will be on change between baseline and 12 months

  2. Quality of Life Assessment of the Bard Venous Stent (BVS) between the baseline classification and the follow-up classification [ Time Frame: 12 months post-index procedure ]
    Emphasis will be on change between baseline and 12 months

  3. Acute Procedure Success of Treated Subjects [ Time Frame: Less than 30 days post index procedure - at the time of discharge following index procedure ]
    Technical success with no major adverse events between index procedure and time of discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655887


  Show 21 Study Locations
Sponsors and Collaborators
C. R. Bard
Investigators
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Principal Investigator: Michael Dake, MD Lead Principal Investigator

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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02655887     History of Changes
Other Study ID Numbers: BPV-14-007
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by C. R. Bard:
Vernacular
Iliofemoral Occlusive Disease

Additional relevant MeSH terms:
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Vascular Malformations
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
May-Thurner Syndrome
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Abnormalities
Congenital Abnormalities