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

This study is checking how a system called Indigo Aspiration helps people with a serious condition called pulmonary embolism (PE). PE happens when a blood clot blocks blood flow to the lungs. The Indigo Aspiration System is a treatment used to remove these clots. We want to see how safe and effective this treatment is over a long period. Researchers will look at how patients recover and their overall health after using the system. The aim is to understand the long-term benefits and any potential downsides of this treatment in real-world settings for UK patients aged 18 and over.

At a glance

Status
Recruiting
Sponsor
Penumbra Inc.
Enrolment target
1,500
Start
25 Jun 2021
Estimated completion
01 Feb 2028

What is this study about?

This study is focused on a treatment for a condition called pulmonary embolism, often shortened to PE. This happens when a blood clot, usually from another part of the body, travels to the lungs and gets stuck, blocking blood flow. This can be a very serious and life-threatening condition.

The Indigo Aspiration System is a special tool doctors use to remove these blood clots from the lungs. This particular study isn't about testing if the system works (it's already used by doctors), but rather looking at its effects over a longer period in real patients. The main goal is to understand how safe it is and how well it helps people recover and live their lives months or even years after the treatment.

By carefully observing patients who have been treated with the Indigo Aspiration System, researchers hope to gather important information about their long-term health, how well their lungs are working, and any side effects. This information will help doctors understand more about the best ways to treat PE and improve care for future patients.

Key takeaways

  • This study focuses on long-term safety and results after treating lung blood clots.
  • It evaluates the Indigo Aspiration System, a device used to remove these clots.
  • The study aims to understand real-world outcomes over an extended period.
  • It's for adults aged 18 and over who have recently had a pulmonary embolism.
  • The goal is to improve care for future patients with this serious condition.

Who may be eligible?

To join this study, you would generally need to: be 18 years old or older; have recently been diagnosed with a new blood clot in your lungs (pulmonary embolism) within the last 14 days; and have been treated with the Indigo Aspiration System using standard medical guidelines.

There are also some reasons why you might not be able to join. For example, if you can't take blood-thinning medicines, have certain types of cancer, or have previously had surgery on your lungs. People who are pregnant or are already part of another medical study that might affect the results also can't join.

The research team will carefully check all these points to make sure the study is safe for everyone involved and that the results are as clear and accurate as possible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you recently been diagnosed with a pulmonary embolism (lung blood clot) in the last 14 days?
  3. Has your doctor decided to treat your lung clot using the Indigo Aspiration System?
  4. Are you able to take blood-thinning medications if needed?
  5. Are you currently pregnant or on ECMO (a type of life support)?
Answer every question to see your result.

What does participation involve?

The study does not specify the exact number of visits or the total length of time you'd be involved. However, as it focuses on "long-term" outcomes, it suggests that doctors will check on your health and recovery over an extended period after your initial treatment. This would involve follow-up appointments and possibly some medical tests to see how you are doing.

Potential risks and benefits

Taking part could help us learn more about the long-term impact of PE treatment, which might benefit future patients. The specific benefits for you would be related to the Indigo Aspiration System itself, which aims to remove lung clots and improve your health. Risks are often associated with any medical procedure or treatment and would be explained by your doctor. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (76)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Long Beach Medical Center
    Verified postcode
    Long Beach, United States· Recruiting
  • Cedars-Sinai Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • UCLA Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • UC Irvine Medical Center
    Verified postcode
    Orange, United States· Recruiting
  • UCSD Jacobs
    Verified postcode
    San Diego, United States· Recruiting
  • Sharp Memorial Hospital
    Verified postcode
    San Diego, United States· Recruiting
  • Christiana Care Hospital
    Verified postcode
    Newark, United States· Recruiting
  • MedStar Washington Hospital Center
    Verified postcode
    Washington D.C., United States· Recruiting
  • Manatee Memorial Hospital
    Verified postcode
    Bradenton, United States· Recruiting
  • Blake Medical Center/Nova Clinical Research
    Unverified
    Brandenton, United States· Recruiting
  • Delray Medical Center, Inc.
    Verified postcode
    Delray Beach, United States· Recruiting
  • University of Florida Shands Hospital
    Verified postcode
    Gainesville, United States· Recruiting

Common questions

What is pulmonary embolism (PE)?

Pulmonary embolism (PE) is a serious condition where a blood clot blocks an artery in your lungs, stopping blood flow. It can be very dangerous.

What is the Indigo Aspiration System?

It's a medical device used by doctors to remove blood clots from the lungs to help patients with pulmonary embolism.

Why is this study happening?

This study wants to learn how safe and effective the Indigo Aspiration System is over a long time for people who have had a pulmonary embolism.

Will I have to take new medicine?

The study is about a device, not new medicine. Your doctor will use the Indigo Aspiration System as part of your treatment, but no new experimental drugs are involved.

Is the Indigo Aspiration System a new and unproven treatment?

No, it's a treatment that doctors already use. This study is looking at its long-term effects and safety in real patients.

How to find out more

Joanne Krasnoff

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of the Long-Term Safety and Outcomes of Treating Pulmo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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