Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00314002
Eligibility Criteria:
Inclusion Criteria:
1. Patients \>= 18 years of age with pulmonary embolism and cardiogenic shock, defined as a systolic arterial pressure \<= 90 mmHg, a drop in systolic arterial pressure \>= 40 mmHg for \>= 15 minutes, or ongoing administration of catecholamines for systemic arterial hypotension
2. Subtotal or total filling defect in the left and/or right main pulmonary artery due to massive PE, as assessed by chest computed tomography or by conventional pulmonary angiography
3. Right ventricular dysfunction on echocardiography: RV systolic hypokinesis and/or RV dilation (optional)
4. Failed thrombolysis or at least one of the following contraindications to PE thrombolysis present:
* Active bleeding
* History of intracranial bleeding
* Surgery, delivery, organ biopsy, puncture of a non-compressible vessel within 10 days
* History of stroke
* Gastrointestinal bleeding within 10 days
* Significant trauma within 15 days
* Head injury requiring hospitalization within 1 year
* Active cancer with known hemorrhagic risk
* Neurosurgery or ophthalmologic surgery within the past year
* Platelets \< 50,000 or INR \>2.0
* Pregnancy
Exclusion Criteria
1. Systemic (paradoxical) embolism in the presence of an atrial septal defect or patent foramen ovale
2. Free floating right heart thrombi, left heart thrombi
3. Life expectancy due to underlying disease less than one month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00314002
Study Brief:
Protocol Section:
NCT00314002