NL-OMON51587撤回不适用
PEERLESS study - PEERLESS study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects must meet each of the following criteria to be included in the study:
- •1. Age * 18 years
- •2. Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary
- •angiographic evidence of any proximal filling defect in at least one main or
- •lobar pulmonary artery
- •3. Classification of intermediate-high-risk PE by ESC Guidelines 20191,
- •including ALL of the following:
- •a. Clinical signs and symptoms consistent with acute PE, or PESI class III-V,
- •or sPESI *1
- •b. Hemodynamically stable
- •c. RV dysfunction on echocardiography or CT
- •d. Elevated cardiac troponin levels
- •4. Intervention planned to begin within 72 hours of the later of either
- •a. Confirmed PE diagnosis
- •b. If transferring from another hospital, arrival at the treating hospital
- •5. Symptom onset within 14 days of confirmed PE diagnosis
排除标准
- •Subjects will be excluded from the study for any of the following criteria:
- •1. Unable to anticoagulate with heparin, enoxaparin or other parenteral
- •antithrombin
- •2. Index presentation with hemodynamic instability that are part of the high-
- •risk PE definition in the ESC Guidelines 20191, including ANY of the following:
- •a. Cardiac arrest OR
- •b. Systolic BP < 90 mmHg or vasopressors required to achieve a BP *90 mmHg
- •despite adequate filling status, AND end-organ hypoperfusion
- •c. Systolic BP < 90 mmHg or systolic BP drop *40 mmHg, lasting longer than 15
- •min and not caused by new-onset arrhythmia, hypovolemia, or sepsis
- •3. Known sensitivity to radiographic contrast agents that, in the
- •Investigator*s opinion, cannot be adequately pre-treated
- •4. Imaging evidence or other evidence that suggests, in the opinion of the
- •Investigator, the patient is not appropriate for catheter-based intervention
- •(e.g. inability to navigate to target location, clot limited to
- •segmental/subsegmental distribution, predominately chronic clot)
- •5. Patient has right heart clot in transit identified at baseline screening
- •6. Life expectancy < 30 days (e.g stage 4 cancer or severe COVID-19 infection),
- •as determined by the Investigator
- •7. Current participation in another drug or device study that, in the
- •Investigator*s opinion, would interfere with participation in this study
- •8. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH)
- •or chronic thromboembolic disease (CTED) diagnosis, per ESC 2019 guidelines1
- •9. Invasive systolic PA pressure *70 mmHg prior to study device entering the
- •10. Administration of bolus or drip/infusion thrombolytic therapy or mechanical
- •thrombectomy for the index PE event within 48 hours prior to enrollment
- •11. Ventriculararrhythmiasrefractorytotreatmentatthetimeofenrollment
- •12. Knowntohaveheparin-inducedthrombocytopenia(HIT)
- •13. 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.,
- •compromise the well-being or that could prevent, limit, or confound the
- •protocol-specified assessments)
- •14. Subject has previously completed or withdrawn from this study
- •15. Patient unwilling or unable to conduct the follow up visits per protocol.
研究者
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