Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

An observational study of Ischemic Stroke and Intracranial Hematoma, run by Penumbra Inc. at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke, Intracranial Hematoma
What is being tested?: Mechanical thrombectomy and Minimally invasive surgery
Type of treatment: Medical device
How many people: 400 participants
Where: 27 sitesUnited States
Study dates: 16 Feb 2021to 3 Aug 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

≥ 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)

Who cannot join

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

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

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

Other trials in United States

About this study

Conditions: Ischemic Stroke, Intracranial Hematoma
Being tested: Mechanical thrombectomy, Minimally invasive surgery
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mechanical thrombectomyDevice
1. Clot specimen collection
2. Extracranial blood collection
Minimally invasive surgeryOther
1. Clot specimen collection
2. Arterial blood collection

Study groups in NCT04693767
Study group	Role	What they receive
Patients with ischemic stroke		Not described Receives: Device: Mechanical thrombectomy
Patients with intracranial hematoma		Not described Receives: Other: Minimally invasive surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Clot Specimen Histology
Numbers of clot specimen for histology analysis
Measured: 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.
Measured: Blood and clot specimen obtained during procedure
Blood and Clot Specimen Proteomics
Numbers of blood and clot specimen for proteomic analysis
Measured: 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.
Measured: Blood and clot specimen obtained during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 20213 Aug 2022

First posted5 Jan 2021
Study start16 Feb 2021
Primary completion22 Jul 2022
Study completion3 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04693767
Sponsor's protocol ID: CLP 15131
Acronym: INSIGHT
Status last verified: Oct 2024
First submitted: 30 Dec 2020
Last updated: 23 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Branscom GA, Seah C, Som T, Vicari J, Dabney AR, Baltan S, Sohrabji F, Pennypacker K, Woodward KB, Rapoport BI, Schulman S, Fraser JF, Kellner CP. Using clinical and thrombus characteristics to predict the etiology of ischemic stroke: An analysis of the INSIGHT registry. J Stroke Cerebrovasc Dis. 2026 Jul;35(7):108665. doi: 10.1016/j.jstrokecerebrovasdis.2026.108665. Epub 2026 May 19.
PubMed 42155823

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Clot in Ischemic Stroke and Hematoma Evacuation
ClinicalTrials.gov ID: NCT04693767
Acronym / sponsor ID: INSIGHT / CLP 15131
Conditions: Ischemic Stroke, Intracranial Hematoma
Study type: Observational
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Penumbra Inc.Industry (pharma, biotech, devices)
Study start: 16 Feb 2021 (actual)
Primary completion: 22 Jul 2022 (actual)
Study completion: 3 Aug 2022 (actual)
First posted: 5 Jan 2021 (actual)
Results: Posted 23 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Patients with ischemic stroke	–	Device: Mechanical thrombectomy
Patients with intracranial hematoma	–	Other: Minimally invasive surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing either ischemic stroke thrombectomy procedures or minimally invasive interventions for intracranial hematoma evacuation

Key inclusion criteria (4 listed)

≥ 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)

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mechanical thrombectomy1. Clot specimen collection 2. Extracranial blood collection	Device	Patients with ischemic stroke
Minimally invasive surgery1. Clot specimen collection 2. Arterial blood collection	Other	Patients with intracranial hematoma

Primary outcome

Clot Specimen Histology
Time frame: Clot specimen obtained during procedure
Numbers of clot specimen for histology analysis
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 Proteomics
Time frame: Blood and clot specimen obtained during procedure
Numbers of blood and clot specimen for proteomic analysis
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.

Results and safety

Results posted to the registry on 23 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Ischemic Stroke	388	388
Patients With Intracranial Hematoma	12	12

Primary outcome: Clot Specimen Histology

Time frame: Clot specimen obtained during procedure. Number. Unit: Count of specimen

Measure	Patients With Ischemic Stroke n = 388	Patients With Intracranial Hematoma n = 12
Value	373	12

Population analysed: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.

Primary outcome: Blood and Clot Specimen Transcriptomics

Time frame: Blood and clot specimen obtained during procedure. Number. Unit: Count of specimen

Measure	Patients With Ischemic Stroke n = 388	Patients With Intracranial Hematoma n = 12
Clot RNA Analyzed	341	9
Blood RNA Analyzed	365	12

Population analysed: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.

Primary outcome: Blood and Clot Specimen Proteomics

Time frame: Blood and clot specimen obtained during procedure. Number. Unit: Count of specimen

Measure	Patients With Ischemic Stroke n = 388	Patients With Intracranial Hematoma n = 12
Clot Protein Analysis	351	12
Blood Protein Analysis	366	12

Population analysed: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.

Primary outcome: Blood and Clot Specimen Genomics

Time frame: Blood and clot specimen obtained during procedure. Number. Unit: Count of specimen

Measure	Patients With Ischemic Stroke n = 388	Patients With Intracranial Hematoma n = 12
Value	387	12

Population analysed: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.

Adverse events

Time frame: Adverse events were collected through 7 days post-procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Ischemic Stroke	38 of 165 (23%)	11 of 165 (6.7%)	86 of 388
Patients With Intracranial Hematoma	0 of 0	0 of 0	3 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42155823Branscom GA, Seah C, Som T, Vicari J, Dabney AR, Baltan S, Sohrabji F, Pennypacker K, Woodward KB, Rapoport BI, Schulman S, Fraser JF, Kellner CP. Using clinical and thrombus characteristics to predict the etiology of ischemic stroke: An analysis of the INSIGHT registry. J Stroke Cerebrovasc Dis. 2026 Jul;35(7):108665. doi: 10.1016/j.jstrokecerebrovasdis.2026.108665. Epub 2026 May 19.

Related trials for Ischemic Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Intracranial Hematoma, run by Penumbra Inc. at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clot Specimen Histology (time frame: Clot specimen obtained during procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04693767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.