Clinical trial NCT04693767: Investigation of Clot in Ischemic Stroke and Hematoma Evacuation
Official title: Investigation of Clot in Ischemic Stroke and Hematoma Evacuation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Intracranial Hematoma
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 400
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 undergoing either ischemic stroke thrombectomy procedures or minimally invasive interventions for intracranial hematoma evacuation

Brief summary: The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 Years of Age
* Frontline treatment with: Penumbra System for ischemic stroke patients eligible for mechanical thrombectomy or Artemis Neuro Evacuation device for intracranial hematoma evacuation in patients eligible for minimally invasive surgery (MIS)
* Extracted thrombus/embolus
* Informed consent is obtained from either the patient or legally authorized representative (LAR)

Exclusion Criteria:

* Pregnancy or positive pregnancy test according to site routine practice (only required for women of child bearing potential; serum or urine acceptable)
* Currently participating in an investigational drug or device clinical trial that may confound the ability to capture clot and/or influence clot composition. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible

Primary outcomes:
measure: Clot Specimen Histology
timeFrame: Clot specimen obtained during procedure
measure: Blood and Clot Specimen Transcriptomics
timeFrame: Blood and clot specimen obtained during procedure
measure: Blood and Clot Specimen Proteomics
timeFrame: Blood and clot specimen obtained during procedure
measure: Blood and Clot Specimen Genomics
timeFrame: Blood and clot specimen obtained during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Desert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center - Phoenix
state: Arizona
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Neuroscience Institute
state: Kentucky
city: Portland
country: United States
facility: MaineHealth
state: Maine
city: Rockville
country: United States
facility: Adventist Healthcare Shady Grove Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Wyoming
country: United States
facility: Metro Health
state: Michigan
city: Jackson
country: United States
facility: St. Dominic Jackson Memorial Hospital
state: Mississippi
city: Fenton
country: United States
facility: SSM St. Clare Healthcare
state: Missouri
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Memorial / Prisma Health
state: South Carolina
city: Knoxville
country: United States
facility: Fort Sanders Regional Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Methodist University
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Center, Memorial Hermann Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Swedish Health Services, Swedish Cherry Hill
state: Washington
city: Tacoma
country: United States
facility: Tacoma General Hosptial
state: Washington
Study officials:
References: