Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Completed

• Conditions: Ischemic Stroke; Intracranial Hematoma
• Interventions: Other: Mechanical thrombectomy; Other: Minimally invasive surgery

• 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

Arm && Interventions

Group	Intervention	Description
Patients with ischemic stroke	Mechanical thrombectomy	-
Patients with intracranial hematoma	Minimally invasive surgery	-

Primary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (27)

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

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

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

Christiana Care; 🇺🇸 Newark, Delaware, United States

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

MaineHealth; 🇺🇸 Portland, Maine, United States

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

Adventist Healthcare Shady Grove Medical Center; 🇺🇸 Rockville, Maryland, United States

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

Metro Health; 🇺🇸 Wyoming, Michigan, United States

Mount Sinai; 🇺🇸 New York, New York, United States

SSM St. Clare Healthcare; 🇺🇸 Fenton, Missouri, United States

Stony Brook University; 🇺🇸 Stony Brook, New York, United States

Westchester Medical Center; 🇺🇸 Valhalla, New York, United States

Miami Valley Hospital; 🇺🇸 Dayton, Ohio, United States

Greenville Memorial / Prisma Health; 🇺🇸 Greenville, South Carolina, United States

Fort Sanders Regional Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Methodist University; 🇺🇸 Memphis, Tennessee, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Tacoma General Hosptial; 🇺🇸 Tacoma, Washington, United States

St. Dominic Jackson Memorial Hospital; 🇺🇸 Jackson, Mississippi, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

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

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Texas Health Center, Memorial Hermann Medical Center; 🇺🇸 Houston, Texas, United States

Swedish Health Services, Swedish Cherry Hill; 🇺🇸 Seattle, Washington, United States