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

Peripheral Vascular Disease Clinical Trial

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)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Iliofemoral Occlusive Disease
• May-Thurner Syndrome
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases
• Venous Disease

• NCT number: NCT02655887
• Study type: Interventional
• Source: C. R. Bard
• Status: Completed
• Phase: N/A
• Start date: June 15, 2016
• Completion date: October 30, 2020