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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04693767
Other study ID # CLP 15131
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 16, 2021
Est. completion date July 2023

Study information

Verified date December 2022
Source Penumbra Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date July 2023
Est. primary completion date July 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Mechanical thrombectomy
Clot specimen collection Extracranial blood collection
Minimally invasive surgery
Clot specimen collection Arterial blood collection

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States Northwestern University Chicago Illinois
United States Miami Valley Hospital Dayton Ohio
United States SSM St. Clare Healthcare Fenton Missouri
United States Greenville Memorial / Prisma Health Greenville South Carolina
United States University of Texas Health Center, Memorial Hermann Medical Center Houston Texas
United States Indiana University Health Methodist Hospital Indianapolis Indiana
United States St. Dominic Jackson Memorial Hospital Jackson Mississippi
United States Baptist Medical Center Jacksonville Florida
United States Fort Sanders Regional Medical Center Knoxville Tennessee
United States University of Kentucky Lexington Kentucky
United States Norton Neuroscience Institute Louisville Kentucky
United States Methodist University Memphis Tennessee
United States Banner Desert Medical Center Mesa Arizona
United States Mount Sinai New York New York
United States Christiana Care Newark Delaware
United States University of Pennsylvania Philadelphia Pennsylvania
United States Banner University Medical Center - Phoenix Phoenix Arizona
United States MaineHealth Portland Maine
United States Virginia Commonwealth University Richmond Virginia
United States Adventist Healthcare Shady Grove Medical Center Rockville Maryland
United States Swedish Health Services, Swedish Cherry Hill Seattle Washington
United States Stony Brook University Stony Brook New York
United States Tacoma General Hosptial Tacoma Washington
United States Westchester Medical Center Valhalla New York
United States George Washington University Washington District of Columbia
United States Metro Health Wyoming Michigan

Sponsors (1)

Lead Sponsor Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clot specimen histology Numbers of clot specimen for histology analysis Clot specimen obtained during procedure
Primary Blood and clot specimen transcriptomics Numbers of blood and clot for RNA sequency Blood and clot specimen obtained during procedure
Primary Blood and clot specimen proteomics Numbers of blood and clot specimen for proteomic analysis Blood and clot specimen obtained during procedure
Primary Blood and clot specimen genomics Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs) Blood and clot specimen obtained during procedure
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