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).
Study Type
OBSERVATIONAL
Enrollment
1,500
Indigo Aspiration System
Safety: Composite of major adverse events
A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury
Time frame: 48 hours
Performance: Change in RV/LV Ratio
Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)
Time frame: 48 hours post-procedure
Quality of Life assessed via PEmb-QoL
Self-assessment of PE related complaints and daily living limitations (including work and social)
Time frame: 90 days post-procedure
Quality of Life assessed via EQ-5D-5L
Self-assessment of activities of daily living
Time frame: 90 days post-procedure
Functional outcome assessed NYHA
Physician assessment of heart failure symptoms and activity level
Time frame: 90 days post-procedure
Functional outcome assessed via 6MWT
Walking distance over a 6 minute period to assess functional capacity
Time frame: 90 days post-procedure
Perceived dyspnea assessed via Borg Scale
Category rating scale to measure perceived dyspnea
Time frame: 90 days post-procedure
Incidence of device related SAE(s)
Time frame: 365 days
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Long Beach Medical Center
Long Beach, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUCLA Medical Center
Los Angeles, California, United States
RECRUITINGUC Irvine Medical Center
Orange, California, United States
RECRUITINGUCSD Jacobs
San Diego, California, United States
RECRUITINGSharp Memorial Hospital
San Diego, California, United States
RECRUITINGChristiana Care Hospital
Newark, Delaware, United States
RECRUITINGMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGManatee Memorial Hospital
Bradenton, Florida, United States
RECRUITINGBlake Medical Center/Nova Clinical Research
Brandenton, Florida, United States
RECRUITING...and 69 more locations
Any-cause mortality
Time frame: Within 30 days
Symptomatic PE recurrence
Time frame: Within 30 days