Investigation of Clot in Ischemic Stroke and Hematoma Evacuation
INSIGHT
1 other identifier
observational
400
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedStudy Start
First participant enrolled
February 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2022
CompletedResults Posted
Study results publicly available
October 23, 2024
CompletedOctober 23, 2024
October 1, 2024
1.4 years
December 30, 2020
September 25, 2023
October 21, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Clot Specimen Histology
Numbers of clot specimen for histology analysis
Clot specimen obtained during procedure
Blood and Clot Specimen Transcriptomics
Numbers of blood and clot for RNA sequency. Only includes successful sample number that was processed.
Blood and clot specimen obtained during procedure
Blood and Clot Specimen Proteomics
Numbers of blood and clot specimen for proteomic analysis
Blood and clot specimen obtained during procedure
Blood and Clot Specimen Genomics
Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs). Only includes successful sample number that was processed.
Blood and clot specimen obtained during procedure
Study Arms (2)
Patients with ischemic stroke
Patients with intracranial hematoma
Interventions
1. Clot specimen collection 2. Extracranial blood collection
1. Clot specimen collection 2. Arterial blood collection
Eligibility Criteria
Patients undergoing either ischemic stroke thrombectomy procedures or minimally invasive interventions for intracranial hematoma evacuation
You may qualify if:
- ≥ 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penumbra Inc.lead
Study Sites (27)
Banner Desert Medical Center
Mesa, Arizona, 85202, United States
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006, United States
Christiana Care
Newark, Delaware, 19713, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Baptist Medical Center
Jacksonville, Florida, 32207, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Norton Neuroscience Institute
Louisville, Kentucky, 40241, United States
MaineHealth
Portland, Maine, 04012, United States
Adventist Healthcare Shady Grove Medical Center
Rockville, Maryland, 20850, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Metro Health
Wyoming, Michigan, 49519, United States
St. Dominic Jackson Memorial Hospital
Jackson, Mississippi, 39216, United States
SSM St. Clare Healthcare
Fenton, Missouri, 63026, United States
Mount Sinai
New York, New York, 10029, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Greenville Memorial / Prisma Health
Greenville, South Carolina, 29605, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916, United States
Methodist University
Memphis, Tennessee, 38104, United States
University of Texas Health Center, Memorial Hermann Medical Center
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Swedish Health Services, Swedish Cherry Hill
Seattle, Washington, 98122, United States
Tacoma General Hosptial
Tacoma, Washington, 98405, United States
Biospecimen
Clot and blood specimen
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brooke Lawson
- Organization
- Penumbra Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2020
First Posted
January 5, 2021
Study Start
February 16, 2021
Primary Completion
July 22, 2022
Study Completion
August 3, 2022
Last Updated
October 23, 2024
Results First Posted
October 23, 2024
Record last verified: 2024-10