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

Sponsor: Penumbra Inc.

NCT ID: NCT04798261

View on ClinicalTrials.gov ↗

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).

Pulmonary Embolism

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: 1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less 2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram 3. Frontline endovascular treatment with the Indigo Aspiration System per IFU 4. Patient is ≥ 18 years of age 5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements Exclusion Criteria: 1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin) 2. Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation 3. Known serious, uncontrolled sensitivity to radiographic agents 4. Life expectancy \< 180 days 5. Patients on ECMO 6. Pregnant patients 7. 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 8. 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

Where Is This Study? (3 UK sites)

Royal Sussex County Hospital

Brighton BN2 5BE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Scott Harfield

uhsussex.research@nhs.net01273 696955 ext. 67497

University Hospital of Wales

Cardiff CF14 4XW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elen de Lacy

PHW.Research@wales.nhs.uk02920 104468

Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

How to Get in Touch

Joanne Krasnoff

Sponsor contact

CONTACT

650-455-4462 jkrasnoff@penumbrainc.com

Aisha Pascua

Sponsor contact

CONTACT

415-601-9561 apascua@penumbrainc.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07