At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Indigo Aspiration System (device)
- How long the study runs
- Study runs about 80 months (dates as stated)
- About the drug or intervention
- Indigo Aspiration System — device: Indigo Aspiration System
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at the long-term safety and outcomes of treating a pulmonary embolism (a blood clot in the lungs) using the Indigo Aspiration System, a device that removes the clot. The sponsor is Penumbra Inc.
Who can take part
- Signs and symptoms of a sudden pulmonary embolism lasting 14 days or less
- A heart-imaging scan showing a right-to-left heart chamber ratio of 0.9 or more
- Being treated with the Indigo Aspiration System as the first treatment
- Aged 18 or over
- Giving informed consent to take part
Who may not be able to
- Unable to take blood-thinning medicines (anticoagulants), such as heparin
- Stage 4 (spread) cancer, active lung cancer, past surgery on the affected lung(s), or chest radiotherapy
- Known serious uncontrolled allergy to X-ray contrast agents
- Life expectancy under 180 days
- On ECMO (a heart-lung support machine)
- Pregnant
- Currently taking part in certain other research studies
- Any other medical, social or psychological condition that, in the researcher's view, would prevent proper consent or taking part
What taking part involves
- • Treatment with the Indigo Aspiration System, a device used to remove the blood clot, following the manufacturer's instructions
- • Long-term follow-up to check safety and outcomes — details of the follow-up schedule are not stated — ask the trial team
Time commitment: Not stated — ask the trial team about visits, duration and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,500
- Started
- 2021-06-25
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for pulmonary embolism
- • Clinical study - 1,500 participants
- • 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 take part?
- • Ages 18 Years and over
- • Diagnosed with pulmonary embolism
Where?
- • Brighton - Royal Sussex County Hospital
- • Cardiff - University Hospital of Wales
- • London - Royal Free Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
- ✓agreement to take part obtained per Institutional Review Board/Ethics Committee requirements
Who cannot take part
- ✗safety concern to systemic or therapeutic doses of anticoagulants (e.g. heparin)
- ✗Stage IV (that has spread) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest...
- ✗Known serious, uncontrolled sensitivity to radiographic agents
- ✗Life expectancy \< 180 days
- ✗Patients on ECMO
See the full criteria
Where Is This Study? (3 UK sites)
Royal Sussex County Hospital
Brighton BN2 5BE, United Kingdom
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
How to Get in Touch
Joanne Krasnoff
Sponsor contactCONTACT
Aisha Pascua
Sponsor contactCONTACT
