A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 44
- 主要终点
- Technical Success of Placement
研究概览
简要总结
The Bard® Denali™ Retrievable Inferior Vena Cava (IVC) study is a prospective, multi-center study which is intended to provide evidence of safety of the placement and retrieval of the Bard® Denali™ Retrievable Inferior Vena Cava Filter in subjects requiring IVC interruption to protect against pulmonary embolism (PE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or their legally authorized representative demonstrates understanding of the nature of the study and voluntarily provides written informed consent prior to any data collection or study procedures.
- •The subject is ≥ 21 years old, must be either a male or non-pregnant female with an expected lifespan sufficient to allow for completion of all study procedures. A negative pregnancy test result (urine or blood) is required prior to implant. If an enrolled female becomes pregnant prior to study completion, participation in the study will be terminated.
- •Based on Investigator judgment, the subject is at increased risk of PE requiring vena caval interruption. Note: Subjects diagnosed with acute DVT and/or PE must have objective confirmation based on imaging evidence of at least one of those diagnoses.
- •Patients without PE or venous thromboembolic disease (VTED) who are at risk of PE may be enrolled in this trial. However, enrollment of these patients will be limited to a maximum of 40% of the total sample size.
- •Based on Investigator's judgment, the subject has patent venous anatomy suitable for femoral or jugular/subclavian access for filter placement (e.g. no excessive tortuosity).
- •The IVC is ≤ 28 mm in diameter at the intended implantation site based on radiographic imaging evidence.
- •Based on Investigator's judgment, the filter can be safely placed such that the position of the filter tip is 1 cm below the lowest renal vein.
- •Retrieval of the filter is expected within 180 days post placement. At the six month follow up, if the Investigator determines that the filter continues to be clinically indicated, the filter may be left in place until the risk of PE has passed or left in permanently. All patients not having their filter retrieved at six months will continue be followed to 24 months or one month post filter retrieval, whichever comes first.
- •The subject has patent venous anatomy suitable for jugular access for retrieval of the filter based on imaging evidence within 48 hours prior to the filter placement procedure. Imaging mode will be at physician's discretion.
- •The subject is willing to comply with the protocol requirements and specified follow-up evaluations.
排除标准
- •The subject has a previously implanted filter in the IVC or superior vena cava (SVC).
- •The subject has a duplicated or left-sided IVC.
- •The subject has a severe spinal deformity that would impede access to the IVC for the filter placement or filter retrieval procedures.
- •The subject has a serum creatinine ≥ 2 mg/dl (and not on dialysis) within seven days of study enrollment. Patients on dialysis are allowed to participate in this trial.
- •The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
- •The subject has a life expectancy of < 25 months.
- •The subject has a known allergy or sensitivity to nickel or titanium.
- •The subject has a known allergy or sensitivity to iodinated contrast media, which cannot be adequately pre-medicated. NOTE: Alternative contrast agents are not permitted for the purposes of this study.
- •The subject is currently participating in an investigational drug or another device study.
结局指标
主要结局
Technical Success of Placement
时间窗: 6 months
Technical success of filter placement is defined as the deployment of the filter such that the physician judges the location to be suitable to provide sufficient mechanical protection against Pulmonary Embolism.
Clinical Success of Placement
时间窗: 6 months
Is the one-sided lower limit of the 95% confidence interval for the observed clinical success rate at least 80%? Clinical success of filter placement is defined as freedom from subsequent Pulmonary Embolism (PE), filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement.
Technical Success of Retrieval
时间窗: 24 months
Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.
Clinical Success of Retrieval
时间窗: 24 months
Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention. Only the 121 successful retrievals are counted here.
次要结局
- Rate of Recurring Pulmonary Embolism(24 months)
- Rate of New or Worsening Deep Vein Thrombosis(6 months)
- Filter Fracture(6 months)
- Filter Migration(6 months)
- Filter Tilt at Placement(Post-placement imaging)
- Filter Tilt at Retrieval(Pre-retrieval imaging)
- Filter Penetration >3mm at Placement(Post-placement)
- Filter Penetration >3mm at Retrieval(Pre-retrieval)