Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3 ("RETRIEVE 3")
This study has been completed.
Information provided by (Responsible Party):
First received: May 6, 2010
Last updated: February 8, 2012
Last verified: February 2012
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3|
Resource links provided by NLM:
Further study details as provided by Crux Biomedical:
Primary Outcome Measures:
- Clinical Success [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.
Secondary Outcome Measures:
- Retrieval Success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Filter Migration [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- VCF Thrombus [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Device Integrity [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Crux Vena Cava Filter System
Subjects at risk for Pulmonary Embolism
Device: Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.
Contacts and Locations