VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior Vena Cava Filter System in Patients at Risk for Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Clinical Success
研究概览
简要总结
This is a prospective, multicenter single arm, nonrandomized study that will include 150 patients at a maximum of 20 investigational sites. It is estimated that it may take 13 months to complete enrollment. Follow-up will continue through 24 months post-implant or one month post-retrieval, whichever occurs first. It is required that filters be retrieved from at least 50 patients and the filter is permanent in at least 50 patients.
详细描述
Verify the effectiveness and safety of the Veniti IVC Filter in accordance with the clinical guidelines published by the Society for Interventional Radiology (SIR) .
The endpoint is clinical success (versus failure) at 6 months after implant or 1 month post retrieval, whichever occurs first, based on the definition provided by the SIR guidelines, as the absence of:
- Procedure failure (assessed at the end of the implant procedure)
- Subsequent pulmonary embolus
- IVC occlusion
- Filter embolization
Secondary assessments include:
Estimating the rate of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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:
- •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:
- •Pulmonary embolus
- •Iliocaval deep vein thrombosis (DVT)
- •Severe trauma with high risk of venous thromboembolism including closed head injury, spinal cord injury, or multiple long bone or pelvic fractures
- •Surgery planned with high risk of venous thromboembolism including procedures such as bariatric, orthopedic, or pelvic surgery
- •Past history of thromboembolic disease undergoing surgery
- •Therapeutic anticoagulation can be achieved, but the patient has:
- •Venous thromboembolism such as pulmonary embolism or DVT with limited cardiopulmonary reserve
- •Massive pulmonary embolism already treated with thrombectomy or any thrombolytic therapy
- •Chronic pulmonary embolism already treated with thrombectomy
- •Large, free floating proximal, e.g., iliofemoral or iliocaval, DVT
- •Iliocaval DVT with planned catheter thrombectomy or thrombolysis treatment OR
- •Medical condition with high risk of venous thromboembolism
排除标准
- •Condition that inhibits radiographic visualization of the IVC
- •Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC including occlusion of the SVC or jugular veins
- •Known IVC transverse diameter at target implant site > 28 mm
- •Known obstructing abdominal mass or anatomy that is not suitable for infra-renal placement of IVC filter
- •Known duplication of IVC or left-sided IVC
- •Severe kyphosis or scoliosis
- •Known IVC thrombosis extending to renal veins, or renal or gonadal vein thrombosis
- •Risk for septic pulmonary embolism
- •Confirmed bacteremia
- •Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, or dialysis dependent.
- •Contrast agent allergy that cannot be adequately pre-medicated
- •Known hypersensitivity to Nitinol (nickel-titanium), platinum, Polyether ether ketone (PEEK), UV Cure Adhesive or Cyanoacrylate Adhesive
- •Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis
- •Life expectance < 6 months
- •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.)
- •Has filter in place or underwent filter retrieval in previous 60 days
- •Simultaneously participating in another therapeutic drug or device clinical trial or has participated in such trial in the 30 days prior to enrollment
- •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
- •Patient does not wish to consent to study or comply with study procedures, including possible 2 year follow up
研究组 & 干预措施
Veniti Inferior Vena Cava Filter
干预措施: Veniti Inferior Vena Cava Filter (Device)
结局指标
主要结局
Clinical Success
时间窗: 6 months
The endpoint is clinical success (versus failure) at 6 months after implant or 1 month post retrieval, whichever occurs first, based on the definition provided by the SIR guidelines, as the absence of: * Procedure failure (assessed at the end of the implant procedure) * Subsequent pulmonary embolus * IVC occlusion * Filter embolization
次要结局
- filter performance rate(24 months)
- Secondary Endpoint(24 months)