Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Completed

• Conditions: Ischemic Stroke; Intracranial Hematoma

• Registration Number: NCT04693767
• Lead Sponsor: Penumbra Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Study Start: 2021-02-16
• Primary Completion: 2022-07-22
• Study Completion: 2022-08-03
• Results First Submitted: 2023-09-25
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Results First Posted: 2024-10-23
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood and Clot Specimen Transcriptomics	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	Blood and clot specimen obtained during procedure	Numbers of blood and clot specimen for proteomic analysis
Clot Specimen Histology	Clot specimen obtained during procedure	Numbers of clot specimen for histology analysis
Blood and Clot Specimen Genomics	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.

Trial Locations

Locations (27)

Banner Desert Medical Center; 🇺🇸 Mesa, Arizona, United States

Banner University Medical Center - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Christiana Care; 🇺🇸 Newark, Delaware, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Baptist Medical Center; 🇺🇸 Jacksonville, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Norton Neuroscience Institute; 🇺🇸 Louisville, Kentucky, United States

MaineHealth; 🇺🇸 Portland, Maine, United States

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