Pulmonary Embolism
Conditions
Interventions
This is a post-marketing, real-world, observational, prospective, multi-center study to evaluate the use of the Indigo aspiration system as a treatment for pulmonary embolism. Patients who meet all in
E04.100.814.842
Sponsors
Centro Universitário do Distrito Federal
Hospital Santa Lucia Sul
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinical signs and symptoms consistent with acute Pulmonary Embolism with duration of 14 days or less. Right Ventricle and Left Ventricle ratio greater than or equal 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram. Frontline endovascular treatment with the Indigo Aspiration System per Instructions For Use. Patient, man or woman, is greater than or equal 18 years of age. Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion criteria
Exclusion criteria: Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin). Stage III or IV cancer or cancer which requires active chemotherapy during the course of the study. Known serious, uncontrolled sensitivity to radiographic agents. Life expectancy less than 180 days. Patients on extracorporeal membrane oxygenation. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury (Major Adverse Events) within 48 hrs ;Change in right ventricule and left ventricule (RV/LV) ratio (matched imaging pairs as available) at 48 hrs post-procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life and functional outcome within 90 days post procedure;Incidence of device related Severe Adverse Event(s);Any-cause mortality within 30 days;Symptomatic pulmonary embolism recurrence within 30 days | — |
Countries
Brazil, Germany, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactLenisa Boas
Hospital Santa Lucia Sul
Outcome results
None listed