Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4
- Conditions
- Pulmonary Embolism
- Registration Number
- NCT01120535
- 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
- 20
- Patient has a permanent or temporary risk of Pulmonary Embolism.
- Patient must provide informed consent At least one of the following conditions -
- Proven PE
- Recurrent PE despite adequate
- 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
- Protection during thrombolysis for iliocaval DVT
- PE with limited cardiopulmonary reserve
- Poor compliance with anticoagulation medication
- High risk of injury worsening on anticoagulation
- Multi-trauma patient with high risk of PE
- Surgical patients at high risk of PE
- Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is 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 the renal veins
- Duplicate IVC
- Gonadal vein thrombosis
- Requires supra-renal placement
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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 Rates of complications related to vena cava filter use. 6 months
Trial Locations
- Locations (3)
Royal Brisbane Womens Hospital
🇦🇺Brisbane, Australia
The Alfred Hospital
🇦🇺Melbourne, Australia
Auckland City Hospital
🇳🇿Auckland, New Zealand
Royal Brisbane Womens Hospital🇦🇺Brisbane, Australia