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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Embolism Venous Thromboembolism Deep Vein Thrombosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No