Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Hematoma Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner Desert Medical Center, Mesa, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical Thrombectomy

Device

Clot specimen collection
Extracranial blood collection

Minimally invasive surgery

Other

Clot specimen collection
Arterial blood collection

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Acronym: INSIGHT

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jan 5, 2021
Registry last updated: Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed