Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Launched by PENUMBRA INC. · Mar 11, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a device called the Indigo Aspiration System, which is used to treat pulmonary embolism (PE), a condition where blood clots block the blood vessels in the lungs. The goal is to understand how well this treatment works in the real world, beyond just the short-term results. The trial is currently looking for participants who are 18 years or older and have been diagnosed with acute PE within the last 14 days. They will need to meet certain health criteria, such as having specific signs of PE and not having conditions that would make it unsafe for them to use blood thinners or participate in the study.

Participants in this trial will receive the Indigo Aspiration treatment and will be monitored over time to see how they respond and if there are any long-term effects. It’s important for potential participants to know that they will need to provide informed consent, meaning they understand what the study involves and agree to take part. This study will help gather valuable information that could improve treatments for future patients with pulmonary embolism.

Gender

ALL

Eligibility criteria

• 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 IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
• • 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