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

NCT ID: NCT02655887

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2020-10-30

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VENOVO™ Venous Stent.

Implant of the VENOVO™ Venous Stent

Group Type: EXPERIMENTAL

VENOVO™ Venous Stent

Intervention Type: DEVICE

VENOVO™ Venous stent placement

Interventions

VENOVO™ Venous Stent

VENOVO™ Venous stent placement

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Dake, MD

Role: PRINCIPAL_INVESTIGATOR

Lead Principal Investigator

Locations

Vascular Breakthroughs, LLC

Darien, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Metro Health Hospital

Wyoming, Michigan, United States

Cox Medical Centers

Springfield, Missouri, United States

Mount Sinai Medical Center

New York, New York, United States

North Carolina Heart and Vascular

Raleigh, North Carolina, United States

Cardiothoracic and Vascular Surgeons

Austin, Texas, United States

Centra Health, Inc., dba Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Sentara Medical Group

Virginia Beach, Virginia, United States

Lake Washington Vascular, PLLC

Bellevue, Washington, United States

CAMC Health Education and Research Institute

Charleston, West Virginia, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

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

Perth, Western Australia, Australia

Uniklinik RWTH

Aachen, , Germany

Klinikum Arnberg

Arnsberg, , Germany

Universitaets-Herrzentrum Freiburg-Bad Krozingen

Bad Krozingen, , Germany

University Hospital Galway

Galway, , Ireland

MUMC Maastricht

Maastricht, , Netherlands

Fundacion de investigacion HM Hospitales

Madrid, , Spain

Guy's & St. Thomas' Hospital

London, , United Kingdom

Countries

United States; Australia; Germany; Ireland; Netherlands; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39968829 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34545448 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BPV-14-007

Identifier Type: -

Identifier Source: org_study_id