Investigation of Clot in Ischemic Stroke and Hematoma Evacuation (INSIGHT)

February 6, 2023 updated by: Penumbra Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Banner Desert Medical Center
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center - Phoenix
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Methodist Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Louisville, Kentucky, United States, 40241
        • Norton Neuroscience Institute
    • Maine
      • Portland, Maine, United States, 04012
        • MaineHealth
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Adventist HealthCare Shady Grove Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Metro Health
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • St. Dominic Jackson Memorial Hospital
    • Missouri
      • Fenton, Missouri, United States, 63026
        • SSM St. Clare Healthcare
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial / Prisma Health
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Fort Sanders Regional Medical Center
      • Memphis, Tennessee, United States, 38104
        • Methodist University
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Center, Memorial Hermann Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Health Services, Swedish Cherry Hill
      • Tacoma, Washington, United States, 98405
        • Tacoma General Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing either ischemic stroke thrombectomy procedures or minimally invasive interventions for intracranial hematoma evacuation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with ischemic stroke
Other: Mechanical thrombectomy
  1. Clot specimen collection
  2. Extracranial blood collection
Patients with intracranial hematoma
Other: Minimally invasive surgery
  1. Clot specimen collection
  2. Arterial blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clot specimen histology
Time Frame: Clot specimen obtained during procedure
Numbers of clot specimen for histology analysis
Clot specimen obtained during procedure
Blood and clot specimen transcriptomics
Time Frame: Blood and clot specimen obtained during procedure
Numbers of blood and clot for RNA sequency
Blood and clot specimen obtained during procedure
Blood and clot specimen proteomics
Time Frame: Blood and clot specimen obtained during procedure
Numbers of blood and clot specimen for proteomic analysis
Blood and clot specimen obtained during procedure
Blood and clot specimen genomics
Time Frame: Blood and clot specimen obtained during procedure
Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs)
Blood and clot specimen obtained during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penumbra Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 16, 2021

Primary Completion (ACTUAL)

July 22, 2022

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (ACTUAL)

January 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP 15131

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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