Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Completed

Conditions studied: Ischemic Stroke, Intracranial Hematoma

In brief

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.

Key facts

Study ID

NCT04693767

Run by

Penumbra Inc.

People needed

400

Starts

2021-02-16

Expected to finish

2022-08-03

Last updated by the study team

2024-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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)

You may not qualify if…

• 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

Where it is running

• 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 D.C., 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
• Adventist Healthcare Shady Grove Medical Center — Rockville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Metro Health — Wyoming, Michigan, United States
• St. Dominic Jackson Memorial Hospital — Jackson, Mississippi, United States
• SSM St. Clare Healthcare — Fenton, Missouri, United States
• Mount Sinai — New York, New York, 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
• University of Pennsylvania — Philadelphia, Pennsylvania, 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
• University of Texas Health Center, Memorial Hermann Medical Center — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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