What is the Purpose of this Study?
This study focuses on individuals who have had a pulmonary embolism (PE) and whose doctor has determined that the clot should be removed to prevent damage to the heart and lungs. A PE is a blood clot in an artery or arteries in the lung. The purpose of the study is to examine the effectiveness of the Indigo Aspiration System for treatment of pulmonary embolism. The Indigo Aspiration System is a medical device that has been cleared by the U.S. Food and Drug Administration (FDA) for removing blood clots from the blood vessels throughout the body, except for the head. Researchers aim to collect information on how patients with PE recover after treatment with the Indigo Aspiration System.
Eligibility
- 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
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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
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
STRIKE-PE: A Prospective, Multicenter Study of the Indigo? Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism