Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism

Inclusion Criteria:

1. Patients who consent for study participation and submit written informed consent withfree will by patient or legally authorized representative.

2. Patients aged between 20 years or above and under 75 years old at the time of obtaininginformed consent.

3. Patients with acute pulmonary embolism within 5 days after the onset.

4. Patients with acute pulmonary embolism with hemodynamic instability and fulfill all ofthe following 4 items:

1. Confirmed to have thrombi, emboli, or disorders in pulmonary circulation detected bypulmonary angiography or computed tomography.

2. Confirmed to have any of the following right ventricular overloads byechocardiography: i) Dilation of right ventricular cavity or hypokinesis in ventricular wall ii) Floating thrombi in pulmonary artery and right heart iii) Paradoxical motion in the interventricular septum iv) Disparity of tricuspid regurgitation pressure v) Enlargement of pulmonary artery

3. Mean pulmonary arterial pressure (PAP) is 20 mmHg or above

4. PaO2 is 65 mmHg or below (confirmed by blood gas analysis)

Exclusion Criteria:

1. Patients with concurrent hemorrhage (e.g., gastrointestinal bleeding, urinary tractbleeding, retroperitoneal bleeding, intracranial bleeding, or hemoptysis).

2. Patients who underwent intracranial or spinal operation or injury within 2 monthsprior to study treatment.

3. Patients with intracranial tumor, arteriovenous malformation, or aneurysm

4. Patients with hemorrhagic diathesis (e.g., vascular purpura, thrombocytopenia,hemophilia)

5. Patients with hypertension of systolic blood pressure >=180 mmHg or diastolic pressure >= 110 mmHg.

6. Patients with a history of cerebrovascular disorder (e.g., cerebral infarction,intracerebral hemorrhage).

7. Patients with severe hepatic disorder (e.g., cirrhosis, severe hepatitis) or severerenal disorder (e.g., renal failure).

8. Patients received thrombolytic drug (t-PA or urokinase) within 7 days prior to studytreatment.

9. Patients with pulmonary cardiac arrest (CPA).

10. Patients with a history of hypersensitivity to monteplase or protein preparations.

11. Pregnant women, women suspected of being pregnant, women who desire to become pregnantduring a period between obtaining informed consent to the final observation, orlactating women.

12. Patients who are judged to be ineligible for study entry by the investigator orsubinvestigator.