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NCT04693767: INSIGHT

Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Completed Results posted Last updated 23 October 2024
What this trial tests

trial testing Mechanical thrombectomy in Ischemic Stroke in 400 participants. Completed in 3 August 2022.

Timeline
16 February 2021
Primary endpoint
22 July 2022
3 August 2022

Quick facts

Lead sponsorPenumbra Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment400
Start date16 February 2021
Primary completion22 July 2022
Estimated completion3 August 2022
Sites27 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Penumbra Inc. — full company profile →

Who can join

18 and older, any sex, with Ischemic Stroke or Intracranial Hematoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clot Specimen Histology Primary · Clot specimen obtained during procedure

Numbers of clot specimen for histology analysis

GroupValue95% CI
Patients With Ischemic Stroke373
Patients With Intracranial Hematoma12
Blood and Clot Specimen Transcriptomics Primary · Blood and clot specimen obtained during procedure

Numbers of blood and clot for RNA sequency. Only includes successful sample number that was processed.

Clot RNA Analyzed
GroupValue95% CI
Patients With Ischemic Stroke341
Patients With Intracranial Hematoma9
Blood RNA Analyzed
GroupValue95% CI
Patients With Ischemic Stroke365
Patients With Intracranial Hematoma12
Blood and Clot Specimen Proteomics Primary · Blood and clot specimen obtained during procedure

Numbers of blood and clot specimen for proteomic analysis

Clot Protein Analysis
GroupValue95% CI
Patients With Ischemic Stroke351
Patients With Intracranial Hematoma12
Blood Protein Analysis
GroupValue95% CI
Patients With Ischemic Stroke366
Patients With Intracranial Hematoma12
Blood and Clot Specimen Genomics Primary · 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.

GroupValue95% CI
Patients With Ischemic Stroke387
Patients With Intracranial Hematoma12

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected through 7 days post-procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With Ischemic Stroke
Serious: 38/165 (23%)
Deaths: 86/388
Patients With Intracranial Hematoma
Serious: 0
Deaths: 3/12

Serious adverse events (7 terms)

ReactionSystemPatients With Ischemic Str…Patients With Intracranial…
Progression of Index StrokeNervous system disorders
OtherInvestigations
Acute Ischemic StrokeNervous system disorders
PneumoniaInfections and infestations
Symptomatic ICHNervous system disorders
New or Worsening Neurological DeficitNervous system disorders
Hemorrhagic StrokeNervous system disorders
Other adverse events (4 terms — click to expand)

ReactionSystemPatients With Ischemic Str…Patients With Intracranial…
Asymptomatic ICHNervous system disorders
Progression of Index StrokeNervous system disorders
Asymptomatic Petechial HemorrhageNervous system disorders
AnemiaBlood and lymphatic system disorders

Most-reported serious reactions: Progression of Index Stroke, Other, Acute Ischemic Stroke, Pneumonia, Symptomatic ICH, New or Worsening Neurological Deficit, Hemorrhagic Stroke.

Data from ClinicalTrials.gov NCT04693767 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Using clinical and thrombus characteristics to predict the etiology of ischemic stroke: An analysis of the INSIGHT registry.
    Branscom GA, Seah C, Som T, Vicari J, et al · · 2026 · PMID 42155823 · DOI 10.1016/j.jstrokecerebrovasdis.2026.108665

Verify or expand the search:

Other trials of Mechanical thrombectomy

Trials testing the same drug.

Other recruiting trials for Ischemic Stroke

Currently open trials in the same condition.

Other Penumbra Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04693767.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing