RecruitingACTRN12612001255875

VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior vena cava filter system in patients at risk for pulmonary embolism


Sponsor

Veniti

Enrollment

30 participants

Start Date

Mar 26, 2013

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a small metal filter called the Veniti Vidi that can be placed inside the body's largest vein (the inferior vena cava) to catch blood clots before they reach the lungs. Blood clots in the lungs — called pulmonary embolism — can be life-threatening. This filter is designed to be retrievable, meaning it can be removed once the risk of clotting has passed. You may be eligible if: - You are 18 years or older - Your doctor believes you need a vena cava filter to prevent pulmonary embolism - You have a deep vein thrombosis (DVT), pulmonary embolism, or are at high risk for blood clots - You cannot take blood thinners, or blood thinners are not controlling your clots You may NOT be eligible if: - You have a known blockage or problem with the vena cava - Your vena cava is larger than 28 mm - Your kidneys are severely impaired (eGFR below 30) or you are on dialysis - You are pregnant or planning to become pregnant during the study - You have an active infection or confirmed bacteria in the bloodstream - You have an allergy to nickel-titanium (Nitinol) or other filter materials Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 cleane

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)

Auckland, New Zealand

United States of America

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ACTRN12612001255875