EUCTR2016-000502-11-GB进行中（未招募）1 期
Study of the Optimum Duration of Acoustic Pulse Thrombolysis (APT) Procedure in the Treatment of Acute Submassive Pulmonary Embolism (OPTALYSE PE). - EKOS and r-tPA thrombolysis in Pulmonary Embolism (OPTALYSE STUDY)
EKOS Corporation0 个研究点目标入组 150 人开始时间: 2016年10月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female = 18 years of age and = 75 years of age
- •2.Computed tomography angiography (CTA) evidence of proximal pulmonary embolism (PE) (filling defect in at least one main or lobar pulmonary artery)
- •3.PE symptom duration =14 days
- •4.Submassive PE: RV/LV diameter = 0.9 from CTA and haemodynamically stable
- •5.Treatment must be started within 48 hours of diagnosis of PE by CTA
- •6.Signed Informed consent obtained from subject or Legally Authorized Representative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
- •2.Recent (within one month) active bleeding from a major organ
- •3.Major surgery within seven days of screening for study enrollment
- •4.Clinician deems the subject high-risk for catastrophic bleeding
- •5.History of heparin-induced thrombocytopaenia (HIT)
- •6.Catheter-based pharmacomechanical treatment for PE within 3 days of study enrollment
- •7.Systolic blood pressure (SBP) less than 90 mm Hg and/or use of vasopressors
- •8.Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
- •9.Evidence of irreversible neurological compromise
- •10.Life expectancy < one year
- •11.Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to APT procedure
- •12.Out-of-Range haematological parameter laboratory values: Haematocrit < 30%, Platelets < 100 thousand/µL, INR > 3,
- •13.Creatinine outside the normal range for the treating institution
- •14.Subject is pregnant (positive pregnancy test; women of childbearing capacity must be tested) or breast feeding
- •15.Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: subjects with non-melanoma primary skin cancers are eligible to participate in the study
- •16.Known allergy, hypersensitivity, or thrombocytopaenia from heparin, r-tPA, or iodinated contrast except for mild-moderate contrast allergies for which steroid pre-medication can be used
研究者
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