None listed
Conditions
Brief 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.
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 Physicia
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.
Sponsors
Veniti
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1)18 years Investigator judges caval filtration clinically indicated for prevention of pulmonary embolism in patient with venous thromboembolic disease or at high risk for venous thromboembolic disease. Patient must meet at least one of the following: 2) Anticoagulant therapy is contraindicated, has failed, cannot be achieved or maintained, must be interrupted, resulted in complication, or places the patient at high risk of complication and the patient has: 2a) Pulmonary embolus 2b) Iliocaval deep vein thrombosis (DVT) 2c) Severe trauma with high risk of venous thromboembolism including closed head injury, spinal cord injury, or multiple long bone or pelvic fractures 2d) Surgery planned with high risk of venous thromboembolism including procedures such as bariatric, orthopedic, or pelvic surgery 2e)Past history of thromboembolic disease undergoing surgery 3) Therapeutic anticoagulation can be achieved, but the patient has: 3a)Venous thromboembolism such as pulmonary embolism or DVT with limited cardiopulmonary reserve 3b)Massive pulmonary embolism already treated with thrombectomy or any thrombolytic therapy 3c)Chronic pulmonary embolism already treated with thrombectomy 3d)Large, free floating proximal, e.g., iliofemoral or iliocaval, DVT 3e)Iliocaval DVT with planned catheter thrombectomy or thrombolysis treatment OR 3f)Medical condition with high risk of venous thromboembolism
Exclusion criteria
Potential subjects will be excluded from the study if any of the following conditions apply: 1)Condition that inhibits radiographic visualization of the IVC 2)Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC including occlusion of the SVC or jugular veins 3)Known IVC transverse diameter at target implant site > 28 mm 4)Known obstructing abdominal mass or anatomy that is not suitable for infra-renal placement of IVC filter 5)Known duplication of IVC or left-sided IVC 6)Severe kyphosis or scoliosis 7)Known IVC thrombosis extending to renal veins, or renal or gonadal vein thrombosis 8)Risk for septic pulmonary embolism 9)Confirmed bacteremia 10)Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, or dialysis dependent. 11)Contrast agent allergy that cannot be adequately pre-medicated 12)Known hypersensitivity to Nitinol (nickel-titanium), platinum, Polyether ether ketone (PEEK), UV Cure Adhesive or Cyanoacrylate Adhesive 13)Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis 14) Life expectance < 6 months 15)Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study. (If a female of child bearing potential wishes to participate, she must have negative pregnancy test within 48 hours of the implantation and any retrieval procedures.) 16) Has filter in place or underwent filter retrieval in previous 60 days 17) Simultaneously participating in another therapeutic drug or device clinical trial or has participated in such trial in the 30 days prior to enrollment 18) Investigator considers patient to be a poor candidate for the study or that including the patient may compromise the study, e.g., suspect patient may not comply with follow up procedures, concomitant conditions 19)Patient does not wish to consent to study or comply with study procedures, including possible 2 year follow up
Outcome results
None listed