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 sites150 target enrollmentOctober 17, 2016

Overview

No summary available.

Registry

who.int

Start Date

October 17, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

EKOS Corporation

•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

•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