Pulmonary Embolism
Conditions
Keywords
Vena Cava, Vena Cava Filter, Pulmonary Embolism, Venous Thromboembolism, Risk of Pulmonary Embolism
Brief summary
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.
Interventions
Inplant of filter in inferior vena cava.
Sponsors
Crux Biomedical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has a permanent or temporary risk of Pulmonary Embolism * Patient or legal guardian must provide written informed consent * At least one of the following conditions * Proven PE * Recurrent PE despite adequate anticoagulation * Contraindication to anticoagulation * Inability to achieve/maintain therapeutic anticoagulation * Iliocaval DVT * Large, free-floating proximal DVT * Massive PE treated with thrombolysis/thrombectomy * Chronic PE treated with thrombectomy * Procetion during thrombolysis for iliocaval DVT * PE with limited cardiopulmonary reserve * Poor compliance with anticoagulation medication * High risk of injury worsend by anticoagulation * Multi-trauma patient with high risk of PE * Surgical patients at high risk of PE * Medical condition with high risk of PE * Patient has documented vena cava diameter of 17-28mm * Patient has IVC anatomy suitable for infra-renal placement * Patient willing to be available for the appropriate follow up.
Exclusion criteria
* Age \<18 years old * Patient has any one of the following conditions * Renal vein thrombosis * IVC thrombosis extending to te renal veins * Duplicate IVC * Gonadal vein thrombosis * Requires supra-renal placement * 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 safe insertion of delivery system * Participation in another drug or device trial * Unable or unwilling to cooperate with study procedures or required follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 6 Months | Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention. |
Secondary
| Measure | Time frame |
|---|---|
| Retrieval Success | 6 Months |
| Filter Migration | 6 Months |
| VCF Thrombus | 6 Months |
| Device Integrity | 6 Months |
Countries
United States
Outcome results
None listed