RecruitingNot Applicable

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

United States1,500 participantsStarted 2021-06-25

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Safety: Composite of major adverse events

Timeframe: 48 hours

Performance: Change in RV/LV Ratio

Timeframe: 48 hours post-procedure

Trial details

NCT IDNCT04798261

SponsorPenumbra Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Joanne Krasnoff

650-455-4462 jkrasnoff@penumbrainc.com

View on ClinicalTrials.gov More Pulmonary Embolism trials