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

October 21, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with ischemic stroke
Device: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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. Only includes successful sample number that was processed.
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). Only includes successful sample number that was processed.
Blood and clot specimen obtained during procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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