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An industry-wide, alternative, post-market study has been initiated
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Vascular Surgery | Atlanta | Georgia | 30342 | United States | ||
| Rex Healthcare |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| Raleigh |
| North Carolina |
| 27607 |
| United States |
| Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D013927 | Thrombosis |