PROTECTOR: Evaluating the Safety and Effectiveness of the Protrieve Sheath in Preventing Clinically Significant Intraprocedural Pulmonary Embolism by Providing Embolic Protection in the IVC During Thrombectomy Procedures to Treat DVT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 25
- 主要终点
- Primary Effectiveness Measure:
研究概览
简要总结
The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.
详细描述
The primary study objective is to evaluate the safety and effectiveness of the Protrieve Sheath in preventing clinically significant intraprocedural pulmonary embolism by providing embolic protection in the IVC during thrombectomy procedures to treat DVT.
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
- •Age ≥ 18 years
- •Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:
- •Bilateral iliofemoral DVT
- •Clot extending into or located in the IVC
- •In-stent thrombosis
- •Presence of thrombosed IVC filter
- •Other features that the investigator deems put the subject at elevated risk for thromboembolism
- •Willing and able to provide informed consent
排除标准
- •Current symptomatic PE
- •Known anatomic inability to place Protrieve device via jugular vein access site
- •Presence of clot extending to the IVC-Right Atrial junction or in the SVC
- •Subject is pregnant
- •Severe allergy to iodinated contrast agents that cannot be mitigated
- •INR > 1.7 if not currently on anticoagulation therapy, platelets < 50,000/μl which cannot be corrected prior to enrollment, or Hemoglobin < 8.0 g/dL
- •Severe renal impairment in patients who are not yet on dialysis that in the Investigator's discretion would pose risk to the patient with the use of marketed contrast agents
- •Subject is participating in another study that may interfere with this study
- •Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
- •Subject has previously completed or withdrawn from this study
- •Limb-threatening circulatory compromise (e.g., phlegmasia)
- •Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)
- •Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
- •Inability to provide therapeutic anticoagulation per Investigator discretion
- •Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- •Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement
研究组 & 干预措施
Protrieve Sheath
The Protrieve Sheath is intended for embolic protection in the inferior vena cava (IVC) to prevent clinically significant intraprocedural pulmonary embolism during mechanical thrombectomy procedures in patients with high risk of embolization.
干预措施: Percutaneous mechanical thrombectomy (PMT) (Device)
结局指标
主要结局
Primary Effectiveness Measure:
时间窗: 24 Hours (+-12 Hours)
a. Clinically significant PE
Primary Safety Measure:
时间窗: 24 Hours (+-12 Hours)
1. Protrieve device-related Major Adverse Events (MAEs) 2. Major Protrieve access site complications
次要结局
- Capture of Thromboembolic Material(24 Hours (+-12 Hours))
- Device Success(24 Hours (+-12 Hours))
- Venous Access Routes(24 Hours (+-12 Hours))
- Estimated Percentage of the Protrieve Funnel Obstructed(24 Hours (+-12 Hours))
- Blood Transfusions(24 Hours (+-12 Hours))