VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior vena cava filter system in patients at risk for pulmonary embolism
Veniti
30 participants
Mar 26, 2013
Interventional
Conditions
Summary
The blockage of the vein leading to the lungs is usually caused by a blood clot coming from the legs. The device is a small metal cage that will be placed in the large vein (inferior vena cava) leading to the heart. The device is placed there to prevent clots from reaching the lungs. The study device is not approved for use in the prevention of reoccurring lung clots. Use of this product is considered investigational in Australia.
Eligibility
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Interventions
Placement of an Inferior Vena Cava Filter involves being given a medicine to make the patient sleepy. The area where the Study Physician will make the puncture (small hole) in the neck will be cleaned with a skin sterilizing liquid. Next the treatment area will be numbed with medicine (similar to Novocain that you get at a dentist). A needle will be used to gain access to the vein and then a small tube with the device inside of it will be moved to the area in the vein where the Study Physician wants the device to be. The Study Physician will then put the device where it is going to stay and pull the small tube out. After the procedure the Study Physician will press on the area of the neck where the needle was until bleeding stops. This procedure will be completed once. The complete procedure will be less than 1 hour in duration. The medication used to numb the area will be different from the medication used to make the patient "sleepy". The protocol does not require specific medications to be used. The choice of the type and amount of medication will be up to the investigator's preference and per local guidelines. The device may be removed as soon as 5 days or may be permanent depending on the participant's condition.
Locations(2)
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ACTRN12612001255875