DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 99
- 主要终点
- Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
研究概览
简要总结
This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.
详细描述
The study will compare the clinical outcomes of patients treated with an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of symptomatic unilateral iliofemoral DVT. Approximately 300 subjects will be enrolled and randomized. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be randomized (1:1, ClotTriever Intervention Arm or Conservative Medical Management Arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years
- •Proximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac veins, alone or in combination
- •Symptom onset within 12 weeks of enrollment in the study
- •Significant symptoms, as defined by a Villalta score > 9
- •Willing and able to provide informed consent
排除标准
- •Bilateral iliofemoral DVT
- •Prior venous stent in the target venous segment
- •IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
- •IVC filter in place at the time of enrollment
- •Limb-threatening circulatory compromise (e.g., phlegmasia)
- •Clot in transit including IVC thrombus presenting as extension of >2cm into the IVC from the CIV
- •Symptomatic PE with right heart strain where the physician judges that a DVT intervention is inappropriate at this time.
- •Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement
- •Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
- •Severe allergy to iodinated contrast agents that cannot be mitigated
- •Hemoglobin < 8.0 g/dL, INR > 1.7 before warfarin was started, or platelets < 50,000/µl which cannot be corrected prior to enrollment
- •Severe renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on dialysis
- •Inability to provide therapeutic anticoagulation per Investigator discretion
- •Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)
- •Recently (< 30 days) had DVT interventional procedure
- •Subject is participating in another study that may interfere with this study
- •Life expectancy < 6 months or chronic non-ambulatory status
- •Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- •Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of ClotTriever per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments)
- •Subject has previously completed or withdrawn from this study
- •Patient unwilling or unable to conduct the follow up visits per protocol
研究组 & 干预措施
Interventional
Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).
干预措施: ClotTriever System (Device)
Conservative Medical Management
Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).
干预措施: Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. (Drug)
结局指标
主要结局
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
时间窗: 180 Days (+-14 Days)
1. Occurrence of treatment failure or therapy escalation 2. Assessment of PTS severity, as defined by the Villalta scale
次要结局
- Assessment of PTS Severity:(180 Days (+-14 Days))
- Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:(10 Days (+- 3 Days))