Crux Biomedical Vena Cava Filter Study - United States
- Conditions
- Pulmonary Embolism
- Interventions
- Device: Inferior Vena Cava Filter
- Registration Number
- NCT01120509
- Lead Sponsor
- Crux Biomedical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
-
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.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Crux Vena Cava Filter System Inferior Vena Cava Filter Subjects at risk for Pulmonary Embolism
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Retrieval Success 6 Months Filter Migration 6 Months VCF Thrombus 6 Months Device Integrity 6 Months
Trial Locations
- Locations (17)
Atlanta Medical Center
🇺🇸Atlanta, Georgia, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Christiana Care
🇺🇸Newark, Delaware, United States
University of Florida Medical Center
🇺🇸Gainesville, Florida, United States
St. Joseph's Hospital
🇺🇸Orange, California, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Upstate Medical Center
🇺🇸Syracuse, New York, United States
St. Francis Hospital
🇺🇸Peoria, Illinois, United States
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of California at Irvine Medical Center
🇺🇸Orange, California, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
University Hospital
🇺🇸Augusta, Georgia, United States
Univeristy of California at Davis Medical Center
🇺🇸Sacramento, California, United States
Jobst Vascular Institute
🇺🇸Toledo, Ohio, United States