NCT01120522CompletedPhase 3
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3
Crux Biomedical2 sites in 1 country17 target enrollmentStarted: May 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Clinical Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Clinical Success
Time Frame: 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 Outcomes
- Retrieval Success(6 months)
- Filter Migration(6 Months)
- VCF Thrombus(6 Months)
- Device Integrity(6 Months)
Investigators
Study Sites (2)
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