Clinical trial NCT02420626: Evaluation of the Short and Long Term Performance and Clinical Outcomes of the Crux Vena Cava Filter System
Official title: Volcano Crux Vena Cava Filter Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pulmonary Embolism
Venous Thromboembolism
Deep Vein Thrombosis
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
First posted: 2015-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are eligible for inclusion if they are scheduled for a vena cava filter implant with the Crux VCF System or have had a Crux VCF implanted within the previous 6 months for any of the following situations:

1. Pulmonary thromboembolism when anticoagulation therapy is contraindicated;
2. Failure of anticoagulation therapy in thromboembolic disease;
3. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
4. Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevention of Pulmonary Embolism
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Vascular Surgery
state: Georgia
city: Raleigh
country: United States
facility: Rex Healthcare
state: North Carolina
city: Knoxville
country: United States
facility: Turkey Creek Medical Center
state: Tennessee
Study officials:
References: