Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Recruitment Status: Recruiting
Start Date: June 25, 2021
End Date: March 01, 2026
Inclusion Criteria:
1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
3. Frontline endovascular treatment with the Indigo Aspiration System per IFU
4. Patient is ≥ 18 years of age
5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion Criteria:
1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
2. Stage III/IV cancer or cancer which requires active chemotherapy during the course of the study
3. Known serious, uncontrolled sensitivity to radiographic agents
4. Life expectancy < 180 days
5. Patients on ECMO
6. Pregnant patients
7. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
8. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
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Conditions:
- Pulmonary Embolism
- Embolism