NCT02655887

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	VENOVO™ Venous Stent	VENOVO™ Venous stent placement

Timeline

• Start date: 2016-06-15
• Primary completion: 2018-06-19
• Completion: 2020-10-30
• First posted: 2016-01-14
• Last updated: 2021-02-04
• Results posted: 2019-06-12

Locations

21 sites across 7 countries: United States, Australia, Germany, Ireland, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated device study