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

C. R. Bard

Status: Completed

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

Treatments: Device: VENOVO™ Venous Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02655887

BPV-14-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

VENOVO™ Venous Stent.

Experimental group

Description:

Implant of the VENOVO™ Venous Stent

Treatment:

Device: VENOVO™ Venous Stent