Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)
Brief Summary: The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.


Options:
A: Inclusion Criteria:

* Computed tomography (CT) evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery)
* PE symptom duration less than or equal to (\<=)14 days
* Informed consent can be obtained from participant or Legally Authorized Representative (LAR)
* Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) or
* Submassive PE (RV diameter-to-LV diameter greater than or equal to \[\>=\] 0.9 on contrast-enhanced chest CT)

Exclusion Criteria:

* Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
* Recent (within one month) or active bleeding from a major organ
* Hematocrit less than (\<) 30 percent (%)
* Platelets \< 100 thousand/microliter (mcL)
* International Normalized Ratio (INR) greater than (\>) 3
* Activated partial thromboplastin time (aPTT) \>50 seconds on no anticoagulants
* Major surgery within seven days of screening for study enrollment
* Serum creatinine \>2 milligrams/deciliter (mg/dL)
* Clinician deems high-risk for catastrophic bleeding
* History of heparin-induced thrombocytopenia (HIT)
* Pregnancy
* Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
* Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
* Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
* Evidence of irreversible neurological compromise
* Life expectancy \<30 days
* Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
* Previous enrollment in the SEATTLE study
B: Inclusion Criteria:

* Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA.
* Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio \> 0.9
* Patient is 18 years of age or older

Exclusion Criteria:

* tPA use within 14 days prior to baseline CTA
* Systolic BP \< 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg
* Pulmonary hypertension with peak PA \> 70 mmHg by right heart catheterization
* History of severe or chronic pulmonary hypertension
* Fi02 requirement \> 40% or \>6 LPM to keep oxygen saturations \>90%
* Hematocrit \< 28%
* Platelets \< 100,000µL
* Serum creatinine \> 1.8 mg/dL
* INR \> 3
* aPTT (or PTT) \> 50 seconds on no anticoagulation
* History of heparin-induced thrombocytopenia (HIT)
* Contraindication to systemic or therapeutic doses of anticoagulants
* Major trauma \< 14 days
* Presence of intracardiac lead
* Cardiovascular or pulmonary surgery within last 7 days
* Cancer requiring active chemotherapy
* Known serious, uncontrolled sensitivity to radiographic agents
* Life expectancy \< 90 days
* Female who is pregnant
* Intracardiac Thrombus
* Patients on ECMO
* Current participation in another investigational study
C: Inclusion Criteria:

* Patients with acute PE symptoms \< 14 days.
* Filling defect by contrast-enhanced chest CT in at least one main or proximal lower lobe pulmonary artery
* Right ventricular dysfunction confirmed by echocardiography where the RV/LV end diastolic diameter ratio is ≥ 1.0.

Exclusion Criteria:

* Age less than 18 years or greater than 80 years
* Index PE symptom duration \> 14 days
* Insufficient echocardiographic image quality in the apical or subcostal four-chamber view that prohibits the measurement of the right and left ventricular end-diastolic dimensions
* Known significant bleeding risk
* Administration of thrombolytic agents, e.g., tissue plasminogen activator, streptokinase, or urokinase, within the previous 4 days
* Active bleeding
* Known bleeding diathesis
* Known coagulation disorder, platelet count \< 100 000/mm3, or previous use of vitamin K antagonists with INR \> 2.5
* History of any intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleed
* Intracranial neoplasm, arteriovenous malformation, or aneurysm
* Recent (\< 3 months) GI bleeding.
* Recent (\< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
* Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
* Estimated glomerular filtration rate (eGFR) \< 50 ml/min as calculated by the Cockroft formula.
* Hemodynamic collapse at presentation defined as: need for cardiopulmonary resuscitation; or systolic blood pressure \< 90 mm Hg for at least 15 min, or drop of systolic blood pressure by at least 40 mm Hg for at least 15 min with signs of end organ hypoperfusion (cold extremities or low urinary output \< 30 mL/h or mental confusion); or need for catecholamine administration to maintain adequate organ perfusion and a systolic blood pressure of \> 90 mm Hg.
* Severe hypertension on repeated readings (systolic \> 180 mmHg or diastolic \> 105 mmHg).
* Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested).
* Participating in any other investigational drug or device study.
* Life expectancy \< 90 days.
* Inability to comply with study assessments (e.g. due to geographic distance).
* Previous enrollment in this study
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
* Known right-to-left shunt, for example from large patent foramen ovale or atrial septal defect
* Large (\>10 mm) right atrial or right ventricular thrombus
D: Inclusion Criteria:

* Consecutive Outpatients/Inpatients with acute first episode of acute pulmonary embolism

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* expected survival \< 2 years
* previous episodes of VTE
* need for anticoagulation for reasons other than VTE
* preexisting severe cardiac or pulmonary diseases
* preexisting diseases that could cause non thromboembolic pulmonary hypertension
* Patients geographically inaccessible for follow up
* Low compliance to anticoagulant therapy and planned diagnostic work-up
* Refusal to give written informed consent

Answer: A