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

Withdrawn

• Conditions: Venous Thromboembolism; Pulmonary Embolism; Deep Vein Thrombosis

• Registration Number: NCT02420626
• Lead Sponsor: Volcano Corporation

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-20
• Status Verified: 2015-12
• Study Start: 2016-01
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-22
• Primary Completion: 2017-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention of Pulmonary Embolism	2 years	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.

Trial Locations

Locations (3)

Northside Vascular Surgery; 🇺🇸 Atlanta, Georgia, United States

Rex Healthcare; 🇺🇸 Raleigh, North Carolina, United States

Turkey Creek Medical Center; 🇺🇸 Knoxville, Tennessee, United States