Indigo Aspiration System for Pulmonary Embolism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Indigo Aspiration System to evaluate its effectiveness and safety in treating pulmonary embolism (PE), a condition where blood clots block lung arteries. Researchers aim to understand the long-term outcomes and safety of this treatment in real-world settings. Suitable participants have experienced pulmonary embolism symptoms within the last two weeks and received a diagnosis via CT scan or echocardiogram.
As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have a contraindication (a specific reason not to use) to anticoagulants like heparin.
What prior data suggests that the Indigo Aspiration System is safe for treating pulmonary embolism?
Research has shown that the Indigo Aspiration System is generally safe for treating pulmonary embolism, a blockage in the lung's blood vessels. The EXTRACT-PE trial found this treatment effective with a low rate of serious side effects, indicating that major complications were rare. Specifically, patients in that trial demonstrated noticeable improvement in heart function, which supports its safety. Studies suggest that the Indigo Aspiration System is well-tolerated for this use.12345
Why are researchers excited about this trial?
The Indigo Aspiration System is unique because it offers a minimally invasive way to treat pulmonary embolism by physically removing blood clots from the lungs. Unlike traditional treatments like anticoagulants, which prevent further clotting but can take time to break down existing clots, the Indigo system directly suctions out the blockage. This immediate action could lead to faster relief of symptoms and improved outcomes for patients. Researchers are excited about this approach because it has the potential to reduce recovery time and lower the risk of long-term complications associated with pulmonary embolism.
What evidence suggests that the Indigo Aspiration System is effective for pulmonary embolism?
Research has shown that the Indigo Aspiration System effectively treats pulmonary embolism (PE), a blockage in the lungs. In the EXTRACT-PE trial, it significantly improved heart function by reducing the RV/LV ratio, an important measurement for PE patients. The trial also reported a low rate of serious side effects, indicating its safety. Another study confirmed its safety and effectiveness for treating submassive acute PE. These findings provide strong evidence that the Indigo Aspiration System can be a helpful treatment for people with PE. Participants in this trial will receive the Indigo Aspiration System to evaluate its effectiveness and safety in treating acute pulmonary embolism.12346
Who Is on the Research Team?
Andrew Sharp, MD
Principal Investigator
University College Dublin and The Mater Misericordiae Hospital
John Moriarty, MD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment for pulmonary embolism using the Indigo Aspiration System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Indigo Aspiration System
Indigo Aspiration System is already approved in United States for the following indications:
- Removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems
- Treatment of pulmonary embolism
Find a Clinic Near You
Who Is Running the Clinical Trial?
Penumbra Inc.
Lead Sponsor