Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4
NCT ID: NCT01120535
Last Updated: 2014-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2010-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Crux Vena Cava Filter System
Subjects at risk for Pulmonary Embolism
Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.
Interventions
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Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Crux Biomedical
INDUSTRY
Responsible Party
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Locations
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Royal Brisbane Womens Hospital
Brisbane, , Australia
The Alfred Hospital
Melbourne, , Australia
Auckland City Hospital
Auckland, , New Zealand
Countries
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Related Links
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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.
Other Identifiers
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Crux04
Identifier Type: -
Identifier Source: org_study_id