Investigation of Clot in Ischemic Stroke and Hematoma Evacuation
NCT ID: NCT04693767
Last Updated: 2024-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
400 participants
OBSERVATIONAL
2021-02-16
2022-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with ischemic stroke
Mechanical thrombectomy
1. Clot specimen collection
2. Extracranial blood collection
Patients with intracranial hematoma
Minimally invasive surgery
1. Clot specimen collection
2. Arterial blood collection
Interventions
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Mechanical thrombectomy
1. Clot specimen collection
2. Extracranial blood collection
Minimally invasive surgery
1. Clot specimen collection
2. Arterial blood collection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Locations
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Banner Desert Medical Center
Mesa, Arizona, United States
Banner University Medical Center - Phoenix
Phoenix, Arizona, United States
Christiana Care
Newark, Delaware, United States
George Washington University
Washington D.C., District of Columbia, United States
Baptist Medical Center
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Neuroscience Institute
Louisville, Kentucky, United States
MaineHealth
Portland, Maine, United States
Adventist Healthcare Shady Grove Medical Center
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Metro Health
Wyoming, Michigan, United States
St. Dominic Jackson Memorial Hospital
Jackson, Mississippi, United States
SSM St. Clare Healthcare
Fenton, Missouri, United States
Mount Sinai
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Miami Valley Hospital
Dayton, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Greenville Memorial / Prisma Health
Greenville, South Carolina, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, United States
Methodist University
Memphis, Tennessee, United States
University of Texas Health Center, Memorial Hermann Medical Center
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Health Services, Swedish Cherry Hill
Seattle, Washington, United States
Tacoma General Hosptial
Tacoma, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLP 15131
Identifier Type: -
Identifier Source: org_study_id
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