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

Pulmonary Embolism Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02394912
Study type Interventional
Source Volcano Corporation
Contact
Status Terminated
Phase N/A
Start date June 2015
Completion date November 9, 2016
View Details
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