Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

NCT ID: NCT04693767

Last Updated: 2024-10-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-16

Study Completion Date

2022-08-03

Brief Summary

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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

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Conditions

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Ischemic Stroke Intracranial Hematoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with ischemic stroke

Mechanical thrombectomy

Intervention Type DEVICE

1. Clot specimen collection
2. Extracranial blood collection

Patients with intracranial hematoma

Minimally invasive surgery

Intervention Type OTHER

1. Clot specimen collection
2. Arterial blood collection

Interventions

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Mechanical thrombectomy

1. Clot specimen collection
2. Extracranial blood collection

Intervention Type DEVICE

Minimally invasive surgery

1. Clot specimen collection
2. Arterial blood collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penumbra Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner Desert Medical Center

Mesa, Arizona, United States

Site Status

Banner University Medical Center - Phoenix

Phoenix, Arizona, United States

Site Status

Christiana Care

Newark, Delaware, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

Baptist Medical Center

Jacksonville, Florida, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Norton Neuroscience Institute

Louisville, Kentucky, United States

Site Status

MaineHealth

Portland, Maine, United States

Site Status

Adventist Healthcare Shady Grove Medical Center

Rockville, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Metro Health

Wyoming, Michigan, United States

Site Status

St. Dominic Jackson Memorial Hospital

Jackson, Mississippi, United States

Site Status

SSM St. Clare Healthcare

Fenton, Missouri, United States

Site Status

Mount Sinai

New York, New York, United States

Site Status

Stony Brook University

Stony Brook, New York, United States

Site Status

Westchester Medical Center

Valhalla, New York, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Greenville Memorial / Prisma Health

Greenville, South Carolina, United States

Site Status

Fort Sanders Regional Medical Center

Knoxville, Tennessee, United States

Site Status

Methodist University

Memphis, Tennessee, United States

Site Status

University of Texas Health Center, Memorial Hermann Medical Center

Houston, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Swedish Health Services, Swedish Cherry Hill

Seattle, Washington, United States

Site Status

Tacoma General Hosptial

Tacoma, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CLP 15131

Identifier Type: -

Identifier Source: org_study_id

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