Catheter Directed Therapy in Intermediate Risk Pulmonary Embolism Patients
Pulmonary Embolism Subacute Massive
About this trial
This is an interventional treatment trial for Pulmonary Embolism Subacute Massive focused on measuring catheter directed therapy, intermediate risk pulmonary embolism
Eligibility Criteria
Inclusion Criteria: Acute pulmonary embolism patients (confirmed by CT pulmonary angiography [CTPA]) symptoms started within 15 days of enrollment intermediate-high risk pulmonary embolism patients , i.e., who have all of the following risk indicators combined :(2) i.Pulmonary Embolism Severity Index (PESI) class III-V or sPESI ≥1, ii.AND RV dysfunction on TTE or CTPA, iii.AND elevated cardiac troponin levels with none of the following high-risk presentations: cardiac arrest, systolic blood pressure <90 mmHg, or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status, or end-organ hypoperfusion. Exclusion Criteria: high risk patients who are hemodynamically unstable (cardiogenic shock, SBP <90 mmHg, or use of intotropic support). low risk patients with no RV dysfunction. Patients with history of CTEPH (or previous acute PE) Patients known to have other pulmonary hypertension, apart from group IV (CTEPH). Patients with sever kidney injury (eGFR <30 mg/dl/1.7m2).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
catheter directed therapy group in intermediate risk pulmonary embolism patients
medical therapy group in intermediate risk pulmonary embolism patients
in this arm, intermediated risk pulmonary embolism patients is treated by intervention in the form of: A. Mechanical embolectomy: by hydromechanical defragmentation by pigta B. Suction embolectomy: using The Penumbra Indigo aspiration system C. Catheter directed thrombolysis:
in this arm, intermediated risk pulmonary embolism patients is treated by routine anticoagulation only.