Evaluation of the Short and Long Term Performance and Clinical Outcomes of the Crux Vena Cava Filter System

Pulmonary Embolism Clinical Trial

Official title:

Volcano Crux Vena Cava Filter Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02420626
• Other study ID #: 140203
• Status: Not yet recruiting
• Phase: N/A
• First received: April 7, 2015
• Last updated: December 8, 2015
• Start date: January 2016
• Est. completion date: May 2019

Study information

• Verified date: December 2015
• Source: Volcano Corporation
• Contact: James Hobbs
• Phone: 336-408-5760
• Email: jhobbs[@]volcanocorp.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux Vena Cava Filter System.

Description:

The Crux VCF Registry is a non-randomized clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux VCF System. The registry includes consecutive patients treated with the Crux VCF in a post-market (commercial) setting with data collection at the implant procedure through 2 years post implant or to filter retrieval, whichever comes first. Patients may also be enrolled (roll-in) from a previous Crux VCF implant within the previous 6 months. Follow up assessment will be performed at 6, 12 and 24 months post-implant and at the time of retrieval, if performed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: May 2019
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 85 Years

Eligibility

Inclusion Criteria:

1. The patient is >18 years of age.

2. Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent.

3. Scheduled for and receives a Crux VCF implant or;

4. Have previously had a Crux VCF implanted within the previous 6 months.

Exclusion Criteria:

1. Patient is scheduled for filter implant, but did not have a Crux VCF filter implanted due to anatomical exclusions or technical failures.

2. Patients unwilling or unable to comply with the protocol and provide informed consent.

3. Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)

4. Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
United States	Northside Vascular Surgery	Atlanta	Georgia
United States	Turkey Creek Medical Center	Knoxville	Tennessee
United States	Rex Healthcare	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Volcano Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of Pulmonary Embolism	The primary objective is to evaluate the long term clinical outcomes of patients treated with the Crux VCF for the prevention of PE over a two year period or up to filter retrieval, whichever comes first.	2 years	No