Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
- Conditions
- Pulmonary Embolism
- Interventions
- Device: Indigo Aspiration System
- Registration Number
- NCT04798261
- Lead Sponsor
- Penumbra Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
- Informed consent obtained per Institutional Review Board/Ethics Committee requirements
- Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
- Stage III/IV cancer or cancer which requires active chemotherapy during the course of the study
- Known serious, uncontrolled sensitivity to radiographic agents
- Life expectancy < 180 days
- Patients on ECMO
- Pregnant patients
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with acute pulmonary embolism Indigo Aspiration System -
- Primary Outcome Measures
Name Time Method Performance: Change in RV/LV Ratio 48 hours post-procedure Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)
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
- Secondary Outcome Measures
Name Time Method Any-cause mortality Within 30 days Symptomatic PE recurrence Within 30 days 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
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
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
Trial Locations
- Locations (57)
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
🇵🇱Warszawa, Poland
Hospital de Santa Cruz
🇵🇹Carnaxide, Portugal
Hospital Universitario Virgen de la Nieves
🇪🇸Granada, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Royal Sussex County Hospital
🇬🇧Brighton, Sussex, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
Krakowski Szpital Specjalistyczny św. Jana Pawła II
🇵🇱Kraków, Poland
Europejskie Centrum Zdrowia Otwock
🇵🇱Otwock, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
🇵🇱Poznań, Poland
Long Beach Medical Center
🇺🇸Long Beach, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Christiana Care Hospital
🇺🇸Newark, Delaware, United States
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Blake Medical Center/Nova Clinical Research
🇺🇸Brandenton, Florida, United States
University of Florida Shands Hospital
🇺🇸Gainesville, Florida, United States
Radiology and Imaging Specialists
🇺🇸Lakeland, Florida, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Baptist Health Miami Cardiac and Vascular Institute
🇺🇸Miami, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
HCA Florida Northside Hospital
🇺🇸Petersburg, Florida, United States
St. Joseph Hospital - BayCare
🇺🇸Tampa, Florida, United States
University Hospital Augusta
🇺🇸Augusta, Georgia, United States
Memorial Hospital Belleville
🇺🇸Belleville, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
KUMC
🇺🇸Kansas City, Kansas, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Charlton Memorial Hospital
🇺🇸Fall River, Massachusetts, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mercy Hospital South
🇺🇸Saint Louis, Missouri, United States
Cooper Health System
🇺🇸Camden, New Jersey, United States
Lovelace Health System
🇺🇸Albuquerque, New Mexico, United States
Bellevue Hospital Center
🇺🇸New York, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
St. Francis Hospital and Heart Center
🇺🇸Roslyn, New York, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
NC Heart and Vascular Research
🇺🇸Raleigh, North Carolina, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
TriHealth Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Methodist Hospital Metropolitan
🇺🇸San Antonio, Texas, United States
Sentara Norfolk General
🇺🇸Norfolk, Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Hospital Santa Lucia Sul
🇧🇷Brasília, Brazil
Universitätsmedizin Mannheim
🇩🇪Mannheim, Baden-Württemberg, Germany
GRN-Klinik Weinheim
🇩🇪Weinheim, Germany
Ospedale Misericordia
🇮🇹Grosseto, Italy
Ospedale San Giovanni Bosco
🇮🇹Torino, Italy