NCT02394912

Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System

Evaluation of the Technical Success of Intravascular Ultrasound (IVUS) Guided Vena Cava Filter (VCF) Placement Using the LUMIFI™ With Crux® VCF System (LUMIFI Clinical Study)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Volcano Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with Crux VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results of the Crux VCF System (fluoroscopic guidance). The study will include enrollment into a roll in phase consisting of 2 study subjects per site prior to enrollment into the primary treatment phase for primary analyses. The purpose of the roll in phase is to assure compliance with site training on the use of the investigational device and protocol workflow.

Conditions

• Pulmonary Embolism
• Deep Vein Thrombosis

Interventions

Type	Name	Description
DEVICE	vena cava filter implantation (LUMIFI with Crux VCF System)

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-11-09
• Completion: 2016-11-09
• First posted: 2015-03-20
• Last updated: 2019-07-30
• Results posted: 2018-06-11

Locations

2 sites across 1 country: United States