A Prospective, Multicenter Study of the IndigoTM Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
Eligibility
You can join if...
Inclusion Criteria:
Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
RV/LV ratio greater than or equal to 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
Frontline endovascular treatment with the Indigo Aspiration System per IFU
Patient is greater than or equal to 18 years of age
Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion Criteria:
Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
Known serious, uncontrolled sensitivity to radiographic agents
Life expectancy less than 180 days
Patients on ECMO
Pregnant patients
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
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