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The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crux Vena Cava Filter System | Experimental | Subjects at risk for Pulmonary Embolism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inferior Vena Cava Filter | Device | Inplant of filter in inferior vena cava. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of complications related to vena cava filter use. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Age <18 years old
Patient has any one of the following conditions:
Vena cava diameter of 17-28mm
Uncontrolled infectious disease
Risk of aseptic PE
Uncontrolled coagulopathy
Existing inferior vena cava filter implant
Life expectancy less than 6 months
Pregnant or planning a pregnancy in the next 6 months
Condition that inhibits radiographic visualization of the IVC
Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
Known hypersensitivity to contract which cannot be pretreated
Access vessels preclude same insertion of delivery system
Participation in another drug or device trial
Unable or unwilling to cooperate with study procedures or required follow-up visits
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane Womens Hospital | Brisbane | Australia | ||||
| The Alfred Hospital |
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| Label | URL |
|---|---|
| Smouse H, Mendes R, Bosiers M et al. The RETRIEVE Trial: Safety and Effectiveness of the Retrieval Crux Vena Cava Filter. JVIR 2013; 24:609-621. | View source |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D016306 | Vena Cava Filters |
| ID | Term |
|---|---|
| D057505 | Embolic Protection Devices |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Melbourne |
| Australia |
| Auckland City Hospital | Auckland | New Zealand |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |