A randomised study to compare the technical difficulty of retrieval between the Bard G2X and the Cook Celect Vena Cava Filter systems in patients at high risk for pulmonary embolism

The Alfred Radiology Department0 个研究点目标入组 160 人开始时间: 2012年10月8日最近更新: 2020年1月13日

适应症

试验速览

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•1.Any patient considered at high risk for pulmonary embolism and is under consideration for placement of a short-term VCF. The patient should have at least one of the following 7 indications.
•a.Patients with evidence of pulmonary embolus or IVC, iliac, or femoral-popliteal deep venous thrombosis and a contraindication, complication, or failure of anticoagulation.
•b.Massive pulmonary embolism with residual deep venous thrombus in a patient at risk for further PE.
•c.Free-floating iliofemoral or IVC thrombus.
•d.Severe cardiopulmonary disease and deep venous thrombosis (e.g., cor pulmonale with pulmonary hypertension).
•e.Poor compliance with anticoagulant medications.
•f.Severe trauma without documented PE or DVT in patient with a closed head injury, spinal cord injury, or multiple long bone or pelvic fractures.
•g.High-risk patients (e.g., immobilized, intensive care patients, prophylactic pre-operative placement in patients with multiple risk factors for venous thromboembolism).
•2.Patient must have patent internal jugular vein.
•3.Age: great than or equal to 18 years
•4.Patient or person responsible must have signed the informed consent form.

•1.Age < 18 years.
•2.Pregnancy.
•3.Uncontrollable coagulopathy.
•4.Vena cava diameter over 30 mm, measured by vena cava sizing catheters.
•5.Vena cava diameter less than 15 mm, measured by vena cava sizing catheters.
•6.Contrast allergy that cannot be adequately pre-medicated.
•7.Simultaneously participating in another investigative drug or device trial, or have a previous IVC filter.

发起方

The Alfred Radiology Department