NCT02046096

Cook IVC Filter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	Günther Tulip® Vena Cava Filter	Temporary or permanent filter placement for the prevention of pulmonary embolism
DEVICE	Cook Celect® Vena Cava Filters	Temporary or permanent filter placement for the prevention of pulmonary embolism

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-12-18
• Completion: 2019-08-09
• First posted: 2014-01-27
• Last updated: 2022-01-20
• Results posted: 2022-01-11

Locations

28 sites across 3 countries: United States, Australia, United Kingdom

Regulatory

• FDA-regulated device study