Pulmonary Embolism
Conditions
Brief 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).
Interventions
DEVICEIndigo Aspiration System
Indigo Aspiration System
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Composite of major adverse events | 48 hours | A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury |
| Performance: Change in RV/LV Ratio | 48 hours post-procedure | Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life assessed via PEmb-QoL | 90 days post-procedure | Self-assessment of PE related complaints and daily living limitations (including work and social) |
| Quality of Life assessed via EQ-5D-5L | 90 days post-procedure | Self-assessment of activities of daily living |
| Functional outcome assessed NYHA | 90 days post-procedure | Physician assessment of heart failure symptoms and activity level |
| Functional outcome assessed via 6MWT | 90 days post-procedure | Walking distance over a 6 minute period to assess functional capacity |
| Perceived dyspnea assessed via Borg Scale | 90 days post-procedure | Category rating scale to measure perceived dyspnea |
| Incidence of device related SAE(s) | 365 days | — |
| Any-cause mortality | Within 30 days | — |
| Symptomatic PE recurrence | Within 30 days | — |
Countries
Australia, Austria, Brazil, Germany, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTJoanne Krasnoff
CONTACTAisha Pascua
PRINCIPAL_INVESTIGATORJohn Moriarty, MD
University of California, Los Angeles
PRINCIPAL_INVESTIGATORAleksander Araszkiewicz, MD, PhD
Uniwersytecki Szpital Kliniczny w Poznaniu
Outcome results
None listed