NCT05003843进行中（未招募）不适用
BOLT-DVT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 229
- 试验地点
- 51
- 主要终点
- Composite of Major Adverse Events
研究概览
简要总结
The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral lower extremity DVT occlusion involving iliac and/or common femoral veins with up to 2 cm extension in the inferior vena cava (IVC) or femoral in combination with iliac veins, including patients with extension of clot into the contralateral common iliac vein Note: Patients with non-iliofemoral DVT in the contralateral limb, who do not require endovascular treatment, may be enrolled
- •Acute thrombotic or thromboembolic occlusion with symptom duration of 14 days or less at presentation
- •Frontline treatment with Indigo Aspiration System in the target venous segment per Investigator decision
- •Patient is ≥18 years of age
- •Informed consent is obtained per Institutional Review Board requirements
排除标准
- •Contraindication to systemic or therapeutic doses of anticoagulants
- •Contraindication to iodinated contrast venography that cannot be adequately premedicated
- •Complete infrarenal IVC occlusion
- •In the index leg: prior DVT
- •Prior stent in target venous segment
- •Treatment of index DVT with thrombolytics within 14 days prior to index procedure
- •Pulmonary embolism (PE) defined as either high (systolic blood pressure < 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management of PE. Low risk PE and/or intermediate low risk PE can be enrolled.
- •Known coagulation disorders both acquired (e.g., Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable state
- •Pregnant patients
- •Life expectancy <1 year due to comorbidities
- •Primary brain, metastatic cancer or marrow malignancies
- •Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
- •Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
- •Pre-existing malpositioned stent(s) that obstructs the ostium of the index iliac vein and contacts the vena cava wall as demonstrated by venography prior to the index procedure
- •Congenital anatomic anomalies of the IVC or iliac veins
研究组 & 干预措施
Single Arm
Other
Use of Indigo Aspiration System in patients with obstruction due to DVT
干预措施: Indigo Aspiration System (Device)
结局指标
主要结局
Composite of Major Adverse Events
时间窗: 48 Hours Post-Procedure
Device related death, major bleeding, new symptomatic pulmonary embolism or re-thrombosis of the target venous segment and serious device related events
Change in Marder Score
时间窗: Index Procedure
Complete or near complete (75% or greater) reduction of venous thrombus from the target venous segment as measured by Marder Score pre- to post-procedure The Marder Score ranges from 0 to 24, with higher scores being worse.
次要结局
- Composite of Major Adverse Events(30 Days Post-Procedure)
- Device Related Adverse Events(24 Months)
- Villalta Scale(24 Months)
研究者
研究点 (51)
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