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

Recruitingn/aAges 18 Years - anyAllPenumbra Inc.
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In plain words

What the trial is, and whether it could suit you

The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less 2. RV/LV ratio โ‰ฅ 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 โ‰ฅ 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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What it tests

  • Indigo Aspiration System
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Where

79 sites
Long Beach Medical Center
Long Beach, United States
Cedars-Sinai Medical Center
Los Angeles, United States
UCLA Medical Center
Los Angeles, United States
UC Irvine Medical Center
Orange, United States
UCSD Jacobs
San Diego, United States
Sharp Memorial Hospital
San Diego, United States
Christiana Care Hospital
Newark, United States
MedStar Washington Hospital Center
Washington D.C., United States

โ€ฆand 71 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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