NCT01305564

A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System

A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The Bard® Denali™ Retrievable Inferior Vena Cava (IVC) study is a prospective, multi-center study which is intended to provide evidence of safety of the placement and retrieval of the Bard® Denali™ Retrievable Inferior Vena Cava Filter in subjects requiring IVC interruption to protect against pulmonary embolism (PE).

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	Denali inferior vena cava filter	The Denali inferior vena cava filter is a mechanical filtration device consisting of two levels of filtration (upper arms, lower legs), a retrieval hook to allow for retrieval using a standard snare, cranial and caudal anchors, and penetration limiters. The Denali filter is made from a laser cut nitinol tube.

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2011-02-28
• Last updated: 2016-03-30
• Results posted: 2015-12-07

Locations

22 sites across 1 country: United States