Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
Brief Summary: To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)


Options:
A: Inclusion Criteria:

* Pulmonary vascular imaging positive for PE within the previous 24 hours
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \>17 years
* Evidence of severe PE: RV hypokinesis on echocardiography, abnormal troponin I or T (any non-normal including indeterminate values, using local reference thresholds) or BNP measurement \>90 pg/mL or NT proBNP \>900 pg/ml (not more than 6 hours prior to CT angiography and not more than 30 hours before enrollment) or a pulse oximetry reading \<95% within previous two hours (\<93% in Denver).

Exclusion Criteria:

* Systolic blood pressure \< 90 mm Hg at time of informed consent
* Do not resuscitate or do not intubate order
* Systemic fibrinolytic treatment within previous 7 days
* Inability to follow-up at 3 months
* Documented gastrointestinal bleeding within previous 30 days
* Active hemorrhage in any of the following sites at the time of enrollment: intraperitoneal, retroperitoneal, pulmonary, uterine, bladder, or nose.
* Head trauma causing loss of consciousness within previous 7 days
* Any history of hemorrhagic stroke
* Ischemic stroke within the past year
* Prior history of heparin-induced thrombocytopenia
* History of intraocular hemorrhage
* Intracranial metastasis
* Known inherited bleeding disorder, e.g., hemophilia
* Platelet count \< 50,000/uL
* Prothrombin time with an INR \>1.7
* Chest, abdominal, intracranial or spinal surgery within the previous 14 days
* Subacute bacterial endocarditis
* Pregnancy (positive pregnancy test)
* Prior enrollment in the study
* Current treatment with fondiparinux, dalteparin, a direct thrombin inhibitor or administration of a glycoprotein inhibitor within the previous 48 hours.
* Known pericarditis
* Allergy to heparins,or tenecteplase
* Elapsed time that would preclude drug or placebo administration within 24 hours after diagnosis
* Evidence of non-end stage kidney injury (creatinine clearance \< 30 ml/min without chronic hemodialysis treatment; chronic hemodialysis-treated patients are eligible)
* Preexisting end-stage cardiopulmonary disease (heart failure with left ventricular ejection fraction \<20%, known severe pulmonary hypertension or other lung disease causing permanent dependence upon oxygen)
* Any other condition that the investigator believes would pose a significant hazard to the subject
B: Inclusion Criteria:

* age between 18 and 85;
* symptomatic PE confirmed by: high probability lung scan, or intermediate probability lung scan and objectively confirmed deep vein thrombosis, or spiral CT-scan or pulmonary angiography or TE echocardiography;
* normal blood pressure (SBP \>100mmHg);
* RVD at echocardiography (see criteria);
* written informed consent.

Exclusion Criteria:

* absence of RVD at echocardiography;
* shock or hypotension (SBP \< 100 mmHg);
* therapeutic heparin (UFH or LMWH) treatment for more than 48 hours prior to randomization;
* administration of thrombolytic agents within the previous 4 days;
* vena cava filter insertion or pulmonary thrombectomy within the previous 4 days
* chronic pulmonary hypertension or severe COPD;
* hypertension defined as blood pressure \>180/110 mm Hg (systolic BP \>180 mm Hg and/or diastolic BP \>110 mm Hg) on a single, reliable measurement during current admission at enrolling site prior to randomisation;
* use of GP IIb/IIIa antagonists within the preceding 7 days;
* significant bleeding disorders either at present or within the past 6 months;
* active peptic ulceration;
* known diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions;
* known haemorrhagic diathesis;
* known arterial aneurysm and known arterial/venous malformation;
* known neoplasm with increased bleeding risk;
* prolonged cardiopulmonary resuscitation (\>10 minutes) in the previous two weeks;
* current oral anticoagulation;
* major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months;
* any known history of stroke or transient ischaemic attack (TIA) or dementia;
* any recent head trauma and any other trauma occurring after onset of the current pulmonary embolism;
* any known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery);
* known subacute bacterial endocarditis;
* known acute pancreatitis;
* known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension
* (oesophageal varices) and active hepatitis;
* pregnancy or lactation or parturition within the previous 30 days;
* women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control;
* treatment with an investigational drug under another study protocol in the past 7 days;
* previous enrolment in this study;
* known hypersensitivity to Tenecteplase, Alteplase, unfractionated heparin, or to any of the excipients;
* anticipated or obvious problem with vascular access;
* any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated;
* inability to follow protocol requirements
C: Inclusion Criteria:

* Must be Age greater than or equal to 18
* Obtain informed written consent.
* Diagnosed with acute pulmonary embolism (PE) (\< 14 days)
* Catheter-directed therapy (CDT) was performed to treat acute PE
D: 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

Answer: D