Status:
RECRUITING
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Lead Sponsor:
Penumbra Inc.
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Brief Summary
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).
Eligibility Criteria
Inclusion
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
- Frontline endovascular treatment with the Indigo Aspiration System per IFU
- Patient is ≥ 18 years of age
- Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion
- 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 \< 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
Key Trial Info
Start Date :
June 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04798261
Start Date
June 25 2021
End Date
February 1 2028
Last Update
January 9 2026
Active Locations (71)
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1
Long Beach Medical Center
Long Beach, California, United States, 90806
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
UCLA Medical Center
Los Angeles, California, United States, 90095
4
UC Irvine Medical Center
Orange, California, United States, 92868