Clinical trial NCT04798261: Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Official title: STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute pulmonary embolism

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).


Eligibility 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

Primary outcomes:
measure: Safety: Composite of major adverse events
timeFrame: 48 hours
measure: Performance: Change in RV/LV Ratio
timeFrame: 48 hours post-procedure
Secondary outcomes:
measure: Quality of Life assessed via PEmb-QoL
timeFrame: 90 days post-procedure
measure: Quality of Life assessed via EQ-5D-5L
timeFrame: 90 days post-procedure
measure: Functional outcome assessed NYHA
timeFrame: 90 days post-procedure
measure: Functional outcome assessed via 6MWT
timeFrame: 90 days post-procedure
measure: Perceived dyspnea assessed via Borg Scale
timeFrame: 90 days post-procedure
measure: Incidence of device related SAE(s)
timeFrame: 365 days
measure: Any-cause mortality
timeFrame: Within 30 days
measure: Symptomatic PE recurrence
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Newark
country: United States
facility: Christiana Care Hospital
state: Delaware
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Brandenton
country: United States
facility: Blake Medical Center/Nova Clinical Research
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Lakeland
country: United States
facility: Radiology and Imaging Specialists
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Baptist Health Miami Cardiac and Vascular Institute
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Petersburg
country: United States
facility: HCA Florida Northside Hospital
state: Florida
city: Tampa
country: United States
facility: St. Joseph Hospital - BayCare
state: Florida
city: Augusta
country: United States
facility: University Hospital Augusta
state: Georgia
city: Belleville
country: United States
facility: Memorial Hospital Belleville
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: KUMC
state: Kansas
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Fall River
country: United States
facility: Charlton Memorial Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Health System
state: New Mexico
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital and Heart Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Good Samaritan Hospital
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: San Antonio
country: United States
facility: Methodist Hospital Metropolitan
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Brasília
country: Brazil
facility: Hospital Santa Lucia Sul
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
state: Baden-Württemberg
city: Weinheim
country: Germany
facility: GRN-Klinik Weinheim
city: Grosseto
country: Italy
facility: Ospedale Misericordia
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny św. Jana Pawła II
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock
city: Poznań
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Warszawa
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
city: Granada
country: Spain
facility: Hospital Universitario Virgen de la Nieves
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: Sussex
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
Study officials:
affiliation: University of California, Los Angeles
name: John Moriarty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin and The Mater Misericordiae Hospital
name: Andrew Sharp, MD
role: PRINCIPAL_INVESTIGATOR
References: